| CTRI Number |
CTRI/2024/07/070088 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2025 |
| 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
|
Effect of Ayurvedic ointment on post operative wound compared to a standard wound care ointment |
|
Scientific Title of Study
|
Evaluation of the comparative efficacy of an
Ayurvedic polyherbal ointment vs Povidone iodine
ointment in the management of postoperative
proctology wounds A RCT |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Sreedevi V |
| Designation |
Assistant Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Shalya tantra
Amrita School of Ayurveda
Clappana PO Kollam
Kollam
KERALA
690525
India |
| Phone |
09947739516 |
| Fax |
|
| Email |
itz.devinair@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Sreedevi V |
| Designation |
Assistant Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Shalya Tantra
Amrita School of Ayurveda
Clappana PO Kollam
Kollam
KERALA
690525
India |
| Phone |
09947739516 |
| Fax |
|
| Email |
itz.devinair@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Sreedevi V |
| Designation |
Assistant Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Shalya Tantra
Amrita School of Ayurveda
Clappana PO Kollam
Kollam
KERALA
690525
India |
| Phone |
09947739516 |
| Fax |
|
| Email |
itz.devinair@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research centre Salod Wardha Maharashtra India 442001
|
|
|
Primary Sponsor
|
| Name |
Dr Sreedevi V |
| Address |
Department of Shalya tantra
Amrita School of Ayurveda
Clappana PO
Kollam District
Kerala
India
690525 |
| Type of Sponsor |
Other [self] |
|
|
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 Sheetal Asutkar |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
Department of Shalya Tantra
Salod Wardha Maharashtra
Wardha
MAHARASHTRA |
9766811974
sheetalasutkar16@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z51||Encounter for other aftercare andmedical care. Ayurveda Condition: SADYOVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Ayurvedic polyherbal ointment, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Povidone Iodine Ointment | 2gm Ointment topical application on wound duration 5 days twice daily |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who can give written informed consent for the clinical trial
Wounds acquired during surgical procedures of proctological disease Fissurectomy, low anal fistulotomy, external haemorroidectomy, sentinel tag excision
Class II clean-contaminated wounds
Patient having post-operative wounds of duration less than 6hrs
Size Maximum Length Maximum Width Maximum Depth 4 cms (L) 4 cms (W)1 cms (D) |
|
| ExclusionCriteria |
| Details |
Patients with post-surgical wounds of duration more than 6 hrs and > 4X4X1 cm 3
Wounds with signs of infection – Redness around, increased skin temperature, swelling, fever
Known Diabetic patients, TB, HTN, HIV, Cancer patients
Post-operative wounds having medico-legal problems.
Post-operative wounds of pediatric and (below 18 yrs) pregnant patients, and of patients
above the age of 60 yrs.
Confounders to wound healing like habit of smoking, alcohol, those on medications like gluco
corticoids, NSAIDS are excluded.
Patients who are not willing to participate in the trial |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain, healing, |
on the 0th day 5 days 7 days 14 th day 21 st day 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| tenderness wound healing assessments |
oth day 5 th day 7 th day 14th day 21st day 28th day |
|
|
Target Sample Size
|
Total Sample Size="166"
Sample Size from India="166"
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
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="6"
Days="5" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is designed as a randomised controlled , patient blinded, single centric, superiority study with two parallel groups and a primary end point of pain reduction and wound healing on 26 days after proctology surgery. Randomisation will be performed with a 1:1 allocation Need for the study A simple cost effective feasible topical application to reduce pain and promote post-operative proctological wound healing which can exponentially reduce the chances of surgical site infection and impact of prolonged hospital stay with increase in QOL in post- surgical patients. |