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CTRI Number  CTRI/2025/03/081856 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 06/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Dhoopana Karma useful in post-operative treatment of Anorectal wounds. 
Scientific Title of Study   Evaluation of add on effect of Gugguladi Dhoopana Varti with topical Khanduchakka ointment against topical Khanduchakka ointment alone in the management of post-operative Anorectal wounds.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sakshi Ghugal 
Designation  PG Scholar 
Affiliation  Mahatma Gandhi Ayurved College And Research Centre, Salod Hirapur 
Address  OPD No. 13 Department of Shalyatantra Mahatma Gandhi Ayurved College And Research Centre Salod Hirapur Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  8329233080  
Fax    
Email  sakshighugal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sheetal Asutkar 
Designation  Head of Department of Shalyatantra 
Affiliation  Mahatma Gandhi Ayurved College And Research Centre Salod Hirapur Wardha 
Address  OPD No. 13 Department of Shalyatantra Mahatma Gandhi Ayurved College And Research Centre Salod Hirapur Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9766811974  
Fax    
Email  sheetalasutkar16@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sheetal Asutkar 
Designation  Head of Department of Shalyatantra 
Affiliation  Mahatma Gandhi Ayurved College And Research Centre Salod Hirapur Wardha 
Address  OPD No. 13 Department of Shalyatantra Mahatma Gandhi Ayurved College And Research Centre Salod Hirapur Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9766811974  
Fax    
Email  sheetalasutkar16@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute Of Higher Education And Research Center Wardha, Maharashtra, India 442001 
 
Primary Sponsor  
Name  Datta Meghe Institute Of Higher Education And Research 
Address  OPD no 13 Department of Shalyatantra Mahatma Gandhi Ayurved College And Research Centre, Salod Hirapur 442001 Maharashtra, India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sakshi Ghugul  Mahatma Gandhi Ayurved College Hospital And Research Centre Salod Hirapur Wardha  Room no 13 Department of Shalyatantra
Wardha
MAHARASHTRA 
8329233080

sakshighugal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K605||Anorectal fistula. Ayurveda Condition: ABIGHATAH, (2) ICD-10 Condition:Z488||Encounter for other specified postprocedural aftercare. Ayurveda Condition: VRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther than Classical(1) Medicine Name: Ajanvruksha, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmProcedure-Dhoopana Karma (Procedure Reference: Sushruta Samhita, Procedure details: Dhoopana Karma for 30 days twice daily)
(1) Medicine Name: Gugguladi Dhoopana Varti, Reference: Sushruta Samhita, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 2(g), Frequency: bd, Duration: 30 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients willing with written informed consent.
2) Patients with age group 18-60 years.
3) Patients with post operative proctology wound will be included after screening.
4) Patients irrespective of sex, occupation and economic status will be included.
 
 
ExclusionCriteria 
Details  1) Immuno-suppressed patients and taking immuno-suppressive medication.
2) Patients having Asthma
3) Uncontrolled diabetes
4) HbsAg reactive patients
5) HIV positive patients
6) Tuberculosis positive patients
7) Known cases of Malignancy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Wound healing and analgesia in post-operative Anorectal wounds  30 Days 
 
Secondary Outcome  
Outcome  TimePoints 
No Recurrence  15 Days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/05/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The most traditional medical system is Ayurveda. The objectives of this science of life are to maintain and improve health as well as to eradicate illness. The three fundamental Ayurvedic aphorisms- Hetu (causes), Linga (symptoms), and Aushadha (therapeutics) —form the foundation of the entire science of Ayurveda. Of these three, Aushadha is crucial to medicine (Chikitsa) because it is the initial stage of disease treatment. Fistula-in-Ano can be correlated with Bhagandara, is a chronically abnormal connection that runs from the ano-rectum to the peri-anal skin and is surrounded by unhealthy granulation tissue. It develops as an external opening on the buttock or perineum as boil also known as Bhagandara Pidika in Ayurveda. Fistula in ano is a crypto-glandular genesis, with inappropriate anal gland drainage and crypto-glandular infection being the primary causes of fistulous tract formation. It can result in discomfort, edema, discharge, and itching. Classification of Fistula in Ano according to Sir Alan Park’s are intersphincteric, trans sphincteric, suprasphincteric, and extra sphincteric. The prevalence of a fistula-in-ano developing from a perianal abscess range between 26% and 38%Fistulotomy and fistulectomy, are the conventional surgical techniques and newer sphincter saving methods are developed such as use of fibrin glue, fistula plugs, Video-Assisted Anal Fistula Treatment (VAAFT), Ligation of The Intersphincteric Fistula Tract (LIFT), Interception of Fistulous Tract and Application of Ksharsutra (IFTAK).

 One of the eight major diseases of Ashtamahagadas is fistula. Sushruta states that a Bhangandara is a tear (Darana) of the perianal region (Bhaga), anus (Guda), and bladder (Basti) with surrounding skin surface. According to the predominance of Doshas, Sushruta has divided the disease into five categories: Vataja- Shataponak, Pittaja-Ushtragreeva, Kaphaja-Parisrave, Tridoshaja-Shambookavarta, and Abhighataj/Trauma-Unmargee. Vagbhata has listed three other types of Bhagandara: Pitta and Kapha dominance: Arshobhagandara (Piles fistula), Vata and Pitta dominance: Parikshepee (horseshoe-shaped fistula), and Vata and Kapha dominance: Riju (straight). Ksharasutra therapy is a widely recognized technique that has the lower recurrence rate (3.33%) amongst all techniques utilized for fistulas in ano. Sterilization is a critical process in various fields, including medicine, pharmaceuticals, food production, and scientific research, aimed at eliminating all forms of microbial life, including bacteria, viruses, fungi, and spores. The primary objective of sterilization is to ensure the safety and efficacy of products and procedures by preventing contamination and infectionDhoopana karma is a natural and traditional method that can be useful in controlling infections. Dhoopana Karma, mentioned in Samhita, presents a promising avenue for clinical application, but nowadays it is underutilized in clinical practices. It stands as an economically prudent option for patient care, serving as a viable alternative to costly and intrusive interventions and possessing strong wound healing and antimicrobial properties. Dhoopana drugs reduce inflammation and promote tissue regeneration for faster healing, preventing infections in anorectal wounds as they are most prone to infection and delayed wound healing. Dhoopana karma with certain medicated herbs will give anti-inflammatory, antimicrobial, and wound healing effects, minimizing the need for antibiotics and steroids. Dhoopana karma helps to prevent the introduction of microorganisms that can cause infections. Dhoopana karma promotes healing, viz., proper sterilization and care; promotes faster and more effective healing of surgical sites; reduces complications; minimizes the risk of infection; reduces the likelihood of complications, such as sepsis or delayed wound healing. Sitz bath is a lukewarm, shallow bath that cleanses and gives local swedan (fomentation) to the perianal region. It gives relief from pain, inflammation, swelling, and irritation in the perianal region.  Sushruta Acharya stated; Gugguladi Dhoopana Varti provides relief from the pain of Arsha and Shotha, while Povidone-iodine is a broad-spectrum antiseptic and used in the management of wound healing and prevention of infections. So, an attempt will be made to evaluate the effect of Gugguladi Dhoopana karma with sitz bath with hot water in the treatment of postoperative fistula wounds. Aim of this study is to evaluate the efficacy of Dhoopana Karma in post-operative Anorectal wounds

 
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