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Review of Literature: Development of 2% Kshara Ointment for Dushta Vrana

Department of Shalya Tantra - PG Scholar Dissertation Review

1. INTRODUCTION

Vrana (wound/ulcer) and its management form the cornerstone of Shalya Tantra (Ayurvedic Surgery). Acharya Sushruta, the "Father of Surgery," devoted extensive attention to wound classification and management in the Sushruta Samhita. When a wound fails to heal within the expected time, or when it is invaded by vitiated Doshas causing characteristic features of purulence, discoloration, and delayed healing, it is termed Dushta Vrana - the infected or chronic non-healing wound.

Kshara, described as a caustic alkaline substance derived from the calcined ashes of medicinal plants, occupies a supreme place among Ayurvedic para-surgical procedures. The present research aims to develop a 2% Kshara Ointment (Kshara Malahara) as a novel topical formulation for the management of Dushta Vrana - combining classical Ayurvedic therapeutic principles with modern pharmaceutical technology.

2. REVIEW OF LITERATURE

2.1 Conceptual Review of Dushta Vrana

2.1.1 Definition and Etymology

The word Vrana is derived from the Sanskrit root Vrana meaning a wound or ulcer - defined by Acharya Sushruta as destruction or discontinuity in body tissues (Shareerasya vrana iti uktam - Sushruta Samhita, Sutrasthana). A Dushta Vrana is one in which the three Doshas (Vata, Pitta, Kapha) localize and cause vitiation (dushana), rendering the wound difficult to heal. It corresponds closely to the modern concept of a chronic non-healing wound or infected wound.

2.1.2 Classical Features (Lakshana) of Dushta Vrana

According to Sushruta Samhita Chikitsa Sthana, Dushta Vrana is characterized by:

Durgandha - foul odour
Bahusrava - copious discharge
Vivarna - abnormal discolouration (blackish, pale or ashy)
Katina sparsha - hardened wound edges
Kandu - pruritus/itching
Atishoola - excessive pain
Atiraaga - excessive redness
Chirokthita - prolonged duration without healing

2.1.3 Types of Dushta Vrana (Dosha-wise)

Vataja Dushta Vrana: Severe pain, blackish colour, highly contracted (Athisanvrita), hardened edges (Atikatina), and deeply seated (Avasanna)
Pittaja Dushta Vrana: Burning sensation, excessive redness, yellowish-green discharge
Kaphaja Dushta Vrana: Itching, pale or white colour, cold to touch, excessive slimy discharge
Sannipataja Dushta Vrana: Combined features; most difficult to treat

2.1.4 Modern Correlation

Dushta Vrana correlates with:

Chronic non-healing wounds (non-healing beyond 6-8 weeks)
Infected surgical wounds
Diabetic foot ulcers
Venous leg ulcers
Pressure ulcers
Traumatic infected wounds

Modern wound healing involves four phases: Hemostasis, Inflammation, Proliferation, and Remodeling. In Dushta Vrana, there is pathological arrest primarily at the inflammatory phase due to persistent microbial load, necrotic tissue, and biofilm formation.

2.2 Shashti Upakrama (60 Treatment Measures for Wounds)

Acharya Sushruta enumerates Shashti Upakrama - 60 treatment measures for wounds in Sushruta Samhita Chikitsa Sthana. Among these, the relevant measures for Dushta Vrana include:

Upakrama	Procedure	Modern Correlate
Shodhana	Wound cleansing/debridement	Wound bed preparation
Ropana	Wound healing	Tissue regeneration
Lekhana	Scraping of unhealthy tissue	Mechanical debridement
Vrana Dhoopana	Fumigation of wound	Antiseptic fumigation
Pichu Dharana	Application of medicated gauze/wick	Wound packing
Vrana Bandhana	Wound dressing/bandaging	Modern dressing

Kshara Karma achieves multiple upakramas simultaneously - performing Shodhana, Lekhana, Ropana, and Krimighna (antimicrobial) actions in one application.

2.3 Kshara - Classical Overview

2.3.1 Definition

Acharya Sushruta defines Kshara in Sutrasthana as a substance possessing Ksharana (corrosive/erosive action) and Kshapana (destroying/eliminating) properties. It is described as a "Biosalt" - an alkaline compound derived from plant ash. Kshara is categorized under Anushastra (accessory surgical instruments), and is described as superior to all other surgical instruments because of its capacity to simultaneously cut, scrape, cleanse, and heal.

"Kshara iti Sarva Shastra Anuttamam" - Kshara is the best among all surgical instruments (Sushruta Samhita, Sutrasthana 11)

2.3.2 Classification

A. Based on mode of administration:

Pratisaraneeya Kshara (topical/external use) - applied directly on the lesion
Paneeya Kshara (internal use) - taken orally in calculated doses

B. Based on potency (Tikshnatva):

Mridu Kshara (mild/gentle) - used for delicate areas and mild lesions
Madhyama Kshara (moderate) - used for moderately severe lesions
Tikshna Kshara (sharp/potent) - used for severe, deep, chronic lesions

2.3.3 Ideal Properties (Guna) of Kshara

According to Sushruta Samhita Sutrasthana Chapter 11, an ideal Kshara should possess the following qualities:

Na Atitikshna - not excessively sharp
Na Atimrudu - not excessively mild
Na Atishukla - not excessively white
Shlakshna - smooth to touch
Pichhila - slimy
Avishyandi - non-spreading/non-flowing
Shiva - neither too hard nor too soft in action
Shighra - rapid in action
Shikhari - stable when placed in a heap
Sukhanirvapya - easy to neutralize

(Karthik et al., IJDDT 2026)

2.3.4 Therapeutic Properties of Kshara

Chhedana - excision/cutting
Bhedana - incision/bursting
Lekhana - scraping of unhealthy tissue
Dahana - chemical cauterization
Pachana - digestion of necrotic matter
Vilayana - dissolution/liquefaction of slough
Darana - bursting/rupture of accumulated pus
Vrana Shodhana - wound cleansing
Vrana Ropana - wound healing
Kled Shoshana - absorption of excessive wound moisture
Krimighna - antimicrobial action
Tridoshaghna - normalizes all three vitiated Doshas

2.3.5 General Scientific Properties

Alkaline nature (high pH) - creates an unfavorable environment for pathogens
Antacid action
Diuretic property (internally)
Depurative (purifying) action
Chemical debridement - saponins, flavonoids, and alkaloids dissolve necrotic tissue

2.4 Kshara Kalpana - Dosage Forms

Various Kshara formulations have been described in classical texts and modern Ayurvedic practice:

2.4.1 Pratisaraneeya Kshara (Topical Kshara)

The most commonly used form for wound management. It is applied directly to the lesion using a probe or spatula. Examples include:

Apamarga Pratisaraneeya Kshara (Achyranthes aspera) - most widely studied
Palasha Pratisaraneeya Kshara (Butea monosperma)
Mulaka Kshara (Raphanus sativus)
Chitraka Kshara (Plumbago zeylanica)

2.4.2 Ksharasutra

A medicated surgical thread coated with Snuhi Ksheera (latex of Euphorbia nerrifolia), Apamarga Kshara, and Haridra (Curcuma longa). Standard preparation involves 21 coatings: 11 of Snuhi alone, 7 of Snuhi + Apamarga Kshara, and 3 of Snuhi + Haridra. Widely used in Bhagandara (fistula-in-ano) and Nadivrana (sinus tracts).

2.4.3 Kshara Pichu

Medicated gauze/wick coated with Kshara, used for wound packing and sustained release of the alkaline agent into the wound bed. Effective in deep Dushta Vrana with sinus formation.

2.4.4 Ksharaplota

A gauze piece coated with Snuhi Ksheera and Kshara, applied over infected wounds. Shekokar and Ukhalkar (IJAM) demonstrated its efficacy in infected wounds, showing significant reduction in pain, discharge, and wound size.

2.4.5 Kshara Taila (Kshara Oil)

Kshara processed with Tila Taila (sesame oil) and other ingredients. Gopika and Rajeshwari (2025, PMID: 40651265) demonstrated the effect of Apamarga Kshara Taila on diabetic pressure ulcers with significant improvement in wound parameters. This represents a stable, lipid-based Kshara formulation analogous to an ointment base.

2.4.6 Kshara Malahara/Ointment (Proposed Novel Form)

A semi-solid topical preparation incorporating Kshara at a controlled concentration (2%) in a suitable ointment base. This novel formulation bridges classical Kshara Karma with modern pharmaceutical technology, providing:

Controlled and sustained delivery of alkaline active
Ease of application without skilled practitioner requirement
Standardized concentration (2%) for consistent therapeutic effect
Improved shelf life and patient compliance

2.5 Source Plants for Kshara Preparation

2.5.1 Apamarga (Achyranthes aspera Linn.)

Family: Amaranthaceae
Part used: Panchanga (whole plant - root, stem, leaf, flower, seed)
Rasa (taste): Katu (pungent), Tikta (bitter)
Guna (property): Laghu (light), Ruksha (dry), Tikshna (sharp)
Vipaka: Katu
Veerya: Ushna (hot potency)
Dosha karma: Kapha Vata shamaka
Karma (action): Krimighna (antimicrobial), Shothahara (anti-inflammatory), Vrana Shodhana, Ropana
Active constituents: Saponins (Achyranthine), alkaloids, flavonoids, betaine, oleanolic acid, potassium salts
pH of prepared Kshara: 10.61-11.12 (Jadav et al., 2015 - PMID: 26834430)

2.5.2 Palasha (Butea monosperma Lam.)

Rasa: Kashaya (astringent), Tikta
Guna: Laghu, Ruksha
Karma: Vrana Shodhana, Ropana, Krimighna, Kushtaghna
Gupta et al. (2014) studied Palasha Kshara in the management of Dushta Vrana, showing excellent Shodhana and Ropana properties.

2.5.3 Snuhi (Euphorbia nerrifolia Linn.)

Used as a Prakshepaka Dravya (adjuvant) to enhance Tikshnatva of Kshara
Contains latex with Tikshna, Ushna, and Krimighna properties

2.6 Pharmaceutical Standardization of Kshara

Jadav, Galib, and Prajapati (2015, PMID: 26834430) established the Standard Manufacturing Process (SMP) for Apamarga Kshara, which is the foundational reference for any Kshara-based formulation:

Preparation Method:

Apamarga Panchanga (whole plant) collected, dried, and cut into small pieces
Burned completely to produce ash (Bhasma)
Ash dissolved in water (ratio 1:6) and left undisturbed overnight
Supernatant filtered through 4-layered clean cloth (21 times traditionally; Sushruta Samhita specifies cloth folding methodology)
Filtrate heated to evaporate water content - yielding solid Kshara
Three successive washes yield: 21.23%, 9.38%, and 4.76% Kshara respectively

Physicochemical Parameters established:

Parameter	APK1	APK2	APK3
pH	10.61	11.12	10.72
Total Ash (%)	-	-	-
Loss on drying (110°C)	Determined	Determined	Determined
Acid insoluble ash	Determined	Determined	Determined
Water soluble extractives	Determined	Determined	Determined

Shrestha, Harisha, and Dudhamal (2018, PMID: 31000993) conducted comparative pharmacognostical analysis of Mridu and Tikshna Apamarga Kshara, establishing microscopic and physicochemical differences between the two grades - important for selecting appropriate potency for 2% ointment formulation.

2.7 Mechanism of Action in Wound Healing

2.7.1 Ayurvedic Mechanism

Kshara acts through the following sequence in Dushta Vrana management:

Dahana/Vilayana: Chemical cauterization dissolves and liquefies necrotic slough
Lekhana: Scraping action removes devitalized and unhealthy granulation tissue
Kled Shoshana: Hygroscopic nature absorbs excessive wound exudate and reduces edema of granulation tissue
Krimighna: Alkaline pH inhibits pathogen growth; antimicrobial phytoconstituents reduce microbial load
Shodhana: Complete wound debridement creates clean wound bed
Ropana: After Shodhana, promotes healthy granulation tissue formation, enhances vascularity, and accelerates re-epithelialization

Once the slough is removed, further application of Kshara should be stopped as it can damage healthy granulation tissue - a critical clinical guideline.

2.7.2 Modern Mechanism

Chemical debridement: High alkaline pH (10.6-11.1) denatures proteins in necrotic tissue, facilitating autolytic and enzymatic debridement
Antimicrobial action: High pH environment inhibits the growth of gram-positive and gram-negative organisms and fungi; flavonoids and saponins (Achyranthine) provide additional antimicrobial activity
Anti-biofilm effect: Alkaline pH disrupts bacterial biofilm matrix - the primary reason for wound chronicity
Hygroscopic effect: Reduces wound edema, decreasing interstitial fluid pressure and improving microvascular perfusion
Angiogenesis promotion: Once debridement is complete, removal of growth-inhibiting factors (MMPs, necrotic debris) promotes VEGF-mediated neovascularization
Re-epithelialization: Clean wound bed with appropriate moisture balance facilitates keratinocyte migration

2.8 Clinical Studies on Kshara in Dushta Vrana

2.8.1 Kshara Karma (Direct Application)

Asma et al. (IJBPAS, 2022) - "Kshara Karma in the Management of Dushtavrana (Chronic Non-healing Wound)": Case report using Palasha Pratisaraneeya Kshara in a chronic wound. Internal medications included Kaishora Guggulu and Manjishtadi Kashaya. The wound achieved complete healing in 3 months with improvement in quality of life. Conclusion: Kshara Karma provides effective debridement enabling the wound to progress through the healing cascade. (Source)

2.8.2 Comparative Study - Kshara Lepa vs. Jaloukavacharana

A comparative study of Apamarga Kshara Lepa and Jaloukavacharana (JAIMS) - Randomized clinical trial (n=40) with 20 subjects in each group:

Group A: Apamarga Pratisaraneeya Kshara Lepa (with Vacha and Chitraka as Prakshepaka Dravyas)
Group B: Jaloukavacharana (leech therapy)

Results showed both groups achieved significant reduction in pain, burning sensation, discharge, and itching. Group A mean pain score reduced from 3.15 to 1.00; Group B from 3.10 to 0.80. The Tridoshaghna, Vilayana, and Krimighna properties of Kshara explained its therapeutic action. Both modalities were found effective, with leech therapy showing slight advantage in burning sensation (due to Sheeta Guna of leech saliva).

2.8.3 Ksharaplota in Dushta Vrana

Shekokar and Ukhalkar (IJAM) - "Study of Efficacy of Ksharaplota in Dushtavrana w.s.r to Infected Wound" - PhD scholars from Department of Shalyatantra, Govt. Ayurved College, Nanded. Ksharaplota (gauze coated with Snuhi Ksheera and Kshara) was applied over infected wounds. Significant improvement was noted in all wound parameters.

2.8.4 Apamarga Kshara Taila in Diabetic Pressure Ulcer

Gopika G and Rajeshwari PN (2025, PMID: 40651265) - "Effects of Apamarga Kshara Taila on diabetic pressure ulcer" - Case report demonstrating that a lipid-based Kshara formulation (oil/taila) effectively managed diabetic pressure ulcers with Vata-Kaphaja features, supporting the concept of using Kshara in a semi-solid base (ointment) for improved contact time and penetration.

2.8.5 Honey (Madhu) in Dushta Vrana

Dudhamal, Gupta, and Bhuyan (2010, PMID: 21455457) - "Role of honey (Madhu) in the management of wounds (Dushta Vrana)" - Established the classical basis for using natural wound-healing agents. Madhu is frequently combined with Kshara as an ointment base due to its Kashaya, Madhura Rasa, hygroscopic properties, and established antimicrobial activity - supporting the choice of honey-beeswax as an ointment base for Kshara ointment.

2.8.6 Systematic Review - Ayurveda Wound Healing Formulations

Dudhamal TS et al. (2023, PMC10424143) - "Review of grey literature on Ayurveda wound healing formulations and procedures" - A systematic review of 273 studies. Key findings:

Kshara (plant alkalies) was used in 8 research studies on wound healing
Malahara (medicated ointments) were used in 9 research studies
Povidone iodine ointment was the most common control group (37 studies)
Kshara provides chemical debridement in non-viable tissue cases
Integrated approach with Kshara debridement saves diabetic limbs from amputation

2.9 Ointment Technology (Malahara Kalpana)

2.9.1 Classical Ointment Bases

Ghrita (ghee) based: Jatyadi Ghrita, Triphala Ghrita
Taila (oil) based: Kshara Taila
Malahar (cream/ointment): Described in Ashtanga Hridayam and modern Ayurvedic practice

2.9.2 Modern Pharmaceutical Considerations for 2% Kshara Ointment

For development of 2% Kshara ointment, the following formulation parameters require investigation:

A. Ointment base selection:

Hydrophilic base (water-soluble) - for easy application and wash-off
Emulsion base (cream type) - for better skin penetration
Petrolatum/soft paraffin base - for occlusive effect
Natural base (beeswax + coconut oil) - aligned with Ayurvedic philosophy

B. Critical formulation challenges:

Maintaining Kshara stability at 2% concentration without pH alteration of the base
Preventing phase separation over shelf life
Ensuring adequate rheology for wound application (consistency, spreadability)
Compatibility of Kshara (high pH 10-11) with the chosen ointment base
Buffering capacity and its effect on wound pH

C. Standardization parameters (proposed):

Physical: Appearance, color, odor, consistency, pH, spreadability
Chemical: Ash value, total alkalinity, water-soluble extractives
Microbiological: Sterility/microbial load limits (as per IP/USP)
Stability: Accelerated stability at 40°C/75% RH (6 months)

2.9.3 Rationale for 2% Concentration

Excessive concentration (Atitikshna) damages healthy granulation tissue
Sub-therapeutic concentration fails to achieve adequate debridement
2% represents the Mridu-Madhyama range, appropriate for Dushta Vrana without causing additional tissue damage
Comparable to established topical agents: 2% Mupirocin ointment (antimicrobial), 2% Nitrofurazone (topical antimicrobial for wounds)

2.10 Related Studies and Drug Reviews

2.10.1 Terminalia Arjuna in Chronic Venous Insufficiency

Pratap Shankar and Ashwathykutty (2024, PMID: 38555178) - Demonstrated the effectiveness of herbal drugs in chronic wound conditions related to venous disease, reinforcing the evidence base for herbal topical preparations.

2.10.2 Katupila (Securinega leucopyrus) in Dushta Vrana

Ajmeer, Dudhamal, and Gupta (2014, PMID: 25558163) - "Topical application of Katupila in Dushta Vrana showing excellent healing effect" - Established that concentrated topical herbal applications on chronic wounds can achieve excellent healing outcomes, supporting the topical ointment concept.

2.10.3 Neem Oil and Haridra in Non-Healing Wounds

Singh, Singh, and Narayan (2014, PMID: 26195902) - Demonstrated efficacy of Neem oil and Haridra (turmeric) in non-healing wounds. Haridra (Curcuma longa) is frequently used as a Prakshepaka Dravya in Kshara formulations and may be incorporated as an adjuvant in the 2% ointment.

2.11 Wound Healing - Modern Perspective

Chronic wound healing involves well-characterized biology relevant to the proposed study:

Wound Bed Preparation (WBP) - The TIME framework (Tissue, Infection/Inflammation, Moisture, Edge of wound) aligns with Ayurvedic Vrana Shodhana-Ropana principles
Debridement - Chemical/enzymatic debridement (Kshara's Vilayana and Lekhana) removes slough enabling healing
Biofilm management - Alkaline pH disrupts bacterial biofilm (primary cause of wound chronicity)
Moist wound healing - Kshara's hygroscopic and Kled-Shoshana properties optimize wound moisture balance
Angiogenesis and re-epithelialization - Post-debridement, Kshara's Ropana properties facilitate tissue regeneration

3. SUMMARY OF REVIEW

Topic	Key Classical Reference	Modern Evidence
Dushta Vrana concept	Sushruta Samhita, Chikitsa Sthana	WHO chronic wound definition
Kshara definition	Sushruta Samhita, Sutrasthana Ch.11	Alkaline debridement concept
Kshara properties	Su.Su. 11, Ashtanga Hridayam	pH 10.6-11.1 (Jadav et al., 2015)
Apamarga Kshara standardization	Sharngadhara Samhita	Jadav et al., 2015 (PMID: 26834430)
Kshara in chronic wounds	Shashti Upakrama, Kshara Karma	Asma et al., 2022; Gopika et al., 2025
Kshara Lepa in Dushta Vrana	Pratisaraneeya Kshara	JAIMS comparative study
Grey literature review	-	Dudhamal et al., 2023 (PMC10424143)
Ointment formulation	Malahara Kalpana	Modern pharmaceutical technology

4. RESEARCH JUSTIFICATION (LACUNAE IN EXISTING KNOWLEDGE)

Based on the review of classical literature and contemporary research, the following gaps justify the present study:

No standardized ointment formulation of Kshara exists with defined concentration (2%), despite Kshara Lepa, Kshara Pichu, and Kshara Taila being well-described
Classical Kshara application requires skilled practitioner involvement and carries risk of excessive caustic action - a controlled 2% ointment addresses both limitations
While Kshara Taila (oil base) has shown efficacy in diabetic ulcers (Gopika et al., 2025), no ointment-base formulation has been studied for Dushta Vrana
Most existing studies are case reports (evidence tier 8) - a clinical trial using a standardized 2% Kshara ointment will provide higher-quality evidence
Modern wound management relies on pH-controlled dressings - Kshara's established alkaline pH makes it an ideal candidate for a standardized wound ointment
The WHO-aligned WBP (Wound Bed Preparation) framework can be applied to validate Kshara's mechanism in controlled clinical settings

5. REFERENCES (Selected Key References)

Sushruta Samhita - Sutrasthana, Chapter 11 (Kshara Karma Vidhi Adhyaya); Chikitsa Sthana (Dushta Vrana Chikitsa)
Ashtanga Hridayam - Sutrasthana, Kshara Vidhana
Sharngadhara Samhita - Madhyama Khanda (Kshara preparation)
Jadav HR, Galib R, Prajapati PK. Pharmaceutical standardization of Apamarga kshara. J Ayurveda Integr Med. 2015 Oct-Dec. [PMID: 26834430]
Shrestha M, Harisha CR, Dudhamal TS. Comparative pharmacognostical analysis through quantitative micrometry and analytical study on Mridu and Tikshna Apamarga Kshara. Ayu. 2018 Jul-Sep. [PMID: 31000993]
Dudhamal TS et al. Review of grey literature on Ayurveda wound healing formulations and procedures - A systematic review. J Ayurveda Integr Med. 2023. [PMC10424143]
Gopika G, Rajeshwari PN. Effects of Apamarga Kshara Taila on diabetic pressure ulcer - A case report. J Ayurveda Integr Med. 2025 Jul-Aug. [PMID: 40651265]
Asma et al. Kshara Karma in the Management of Dushtavrana (Chronic Non-healing Wound). IJBPAS. 2022 Mar; 11(3).
Shekokar AV, Ukhalkar VP. Study of Efficacy of Ksharaplota in Dushtavrana w.s.r to Infected Wound. Int J Ayurvedic Med.
Karthik KV, Hemantha Kumar P, Koriya H et al. Role of Kshara Kalpana in Ayurvedic Surgical Practices: A Narrative Review. IJDDT. 2026; 16(48s):1105-1122.
Gupta S, Gupta SJ, Singh SK. Role of Palash (Butea monosperma) Kshara in the management of Dushta Vrana. Int J Ayurveda Pharma Res. 2014; 2:86-93.
A comparative study of Apamarga Kshara Lepa and Jaloukavacharana in the management of Dushta Vrana. JAIMS.
Dudhamal TS, Gupta SK, Bhuyan C. Role of honey (Madhu) in the management of wounds (Dushta Vrana). Int J Ayurveda Res. 2010. [PMID: 21455457]
Ajmeer AS, Dudhamal TS, Gupta SK. Topical application of Katupila in Dushta Vrana. Ayu. 2014. [PMID: 25558163]
Hemantha Kumar P, Koriya H. Coexisting pilonidal sinus and anal fistula: Management with Kshara Karma and Ksharasutra. J Ayurveda Integr Med. 2025. [PMID: 39837200]
Han G, Ceilley R. Chronic Wound Healing: A Review of Current Management and Treatments. Adv Ther. 2017; 34(3):599-610. [PMID: 28108895]

Note for PG Scholar: This review of literature covers all four major domains required for a Shalya Tantra dissertation: (1) Conceptual review of the disease (Dushta Vrana), (2) Review of the drug/procedure (Kshara Kalpana), (3) Review of the formulation (Malahara / ointment technology), and (4) Review of contemporary clinical studies. For the dissertation, each section should be expanded further with direct quotations from classical texts (mula granthas) with chapter-verse references, and the formulation development chapter should include pharmacopoeial standards from Ayurvedic Pharmacopoeia of India (API) and WHO Guidelines on Safety Monitoring of Herbal Medicines.

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