| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other 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: - | | 2 | Intervention Arm | Procedure | - | 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 |
|
|
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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
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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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 infection. Dhoopana 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 |