| CTRI Number |
CTRI/2025/05/086344 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the efficacy of Sarivamula Taila varti with Povidone iodine solution dressing in the post - operative management of Gudagata vidradhi within 15 days.
|
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to evaluate the efficacy of Sarivamula
Taila varti with Povidone Iodine solution in the post - operative management of Gudagata Vidradhi.
|
| 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 Ashwini Kirtikumar Patel |
| Designation |
PG scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third
floor,Shalyatantra department Sector no.25 Pradhikaran, Nigdi
Pune
MAHARASHTRA
411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9145174770 |
| Fax |
|
| Email |
ashwinipatel1113@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Banarase |
| Designation |
Professor and H.O.D |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third
floor,Shalyatantra department Sector no.25 Pradhikaran, Nigdi
Pune
MAHARASHTRA
411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9423207569 |
| Fax |
|
| Email |
dr.madhavibanarase209@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhavi Banarase |
| Designation |
Professor and H.O.D |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third
floor,Shalyatantra department Sector no.25 Pradhikaran, Nigdi
Pune
MAHARASHTRA
411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9423207569 |
| Fax |
|
| Email |
dr.madhavibanarase209@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre,Third floor,Shalyatantra department
Sector no.25,Pradhikaran,Nigdi Pune Maharashtra 411044 india |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre Nigi Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third floor,Shalyatantra
department Sector no.25,Nigdi Pradhikaran,Pune 411044 Maharastra
,India |
| Type of Sponsor |
Private medical college |
|
|
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 Ashwini Kirtikumar Patel |
Ayurved Rugnalaya and Snowbell Multi-speciality Hospital, Nigdi Pune |
Ayurved Rugnalaya
and Snowbell Multispeciality
Hospital,
Shalyatantra
Department, OPD No
123A Pradhikaran
Nigdi Pune
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9145174770
ashwinipatel1113@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: GUDAJAVIDRADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Povidone Iodine Solution , Reference: NA, Route: Topical, Dosage Form: Varti/ Suppository, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: No any | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sarivamula Taila , Reference: Yogaratnakar Uttaraardha , Route: Topical, Dosage Form: Varti/ Suppository, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: No any |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
i) Patients with post-operative I & D patients of perianal abscess.
ii) Age group = 18 to 40 years
iii)Patient will be selected irrespective of gender |
|
| ExclusionCriteria |
| Details |
i)Patients
with Supralevator abscess.
ii)Patients with Known case of DM,TB,HIV,Ulcerative Colitis,Crohn’s Disease,CA Rectum.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The effect of Sarivamula Taila varti will be accessed with the effect of Povidone Iodine solution dressing in Gudagata Vidradhi after 15 days
Assessment will be done by criteria like Vranasrava(Discharge),Vranatala(Base of the wound),Vranagandha(smell),Kathinya(Indur ation),Jwar(Fever),Shula(Pain)
|
Patient will be followed
up on 3rd , 5th,7th,10th, and then on 16th day
|
|
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Secondary Outcome
|
|
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Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
11/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Piles, Fissure, Fistula, Perianal abscess are common ano-rectal diseases in human beings Acharya Sushruta, the father of Indian surgery has scientifically classified in a systematic manner a wealth of clinical material and the principle of management of vidradhi (Abscess), which are valid even today. An ano-rectal abscess originates from an infection arising in the crypto-glandular epithelium lining of the anal canal spreading into adjacent spaces and may resulting in Fistulas. Acharya Sushruta, mentioned BhedanaKarma followed by Visravana Karma (incision & Drainage) to be done at the most prominent parts for the evacuation of doshas (pus).So, after the bhedan and visravan karma (incision & Drainage) the treatment to be followed in accordance to healing of the wound (vrana) is also well explained by Acharya Sushruta and Acharya Vagbhatt.Yoga Ratnakar, explained Sariva mula as sarva vrana shodhak. Therefore, we will being using it in the management as of vrana(wound).In Sushruta Samhita "Shasti Upakramas” are described for the Treatment of Vrana(wound). One of them which is taken for the present research work is“Tailam” (Medicated oil). Rationale of the study- Though many antimicrobial agents are available in the market, Povidone-iodine have remained popular after decades of use for antisepsis and wound healing property due to its favourable efficacy and tolerability . But today’s need is to prepare a simple remedy which is easily applicable, cost effective and also promotes wound healing. Thus, this Ayurvedic formulations have immense potential for the management of wounds. These natural agents induce healing and regeneration of tissue by multiple mechanisms like encouraging blood clotting, fighting toxins and accelerate the healing of wounds. In this study an attempt is made to observe the effect of "Sarivamula Taila varti" in postoperative management of Gudagata Vidradhi.
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