| CTRI Number |
CTRI/2025/06/089796 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Post Operative Pain Managment] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Pain managment in post operated bhagandara patients with shunthyadi churna vati |
|
Scientific Title of Study
|
Randomized comparative clinical study of Shunthyadi Churna Vati with Triphala Guggul Vati in post-operative pain management after open fistulectomy in Bhagandara (Fistula in Ano) in the age group 18-60 years. |
| 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 Nayana Kishor Deshmukh |
| Designation |
PG scholar M.S. Shalyatantra |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya, Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K.Ayurved Rugnalaya, Department of Shalyatntra, Ground floor OPD No.05, Yavatmal Yavatmal MAHARASHTRA 445001 India
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
7057967672 |
| Fax |
|
| Email |
deshmukhnayana024@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVihar R Bidwai |
| Designation |
Associate Professor, M.S.(Shalya), MBA, PhD(Sch.), FARCS & PG Guide |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya, Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and L.K.Ayurved Rugnalaya Yavatmal MAHARASHTRA 445001 India
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9822299174 |
| Fax |
|
| Email |
drviharbidwai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nayana Kishor Deshmukh |
| Designation |
PG scholar M.S. Shalyatantra |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya, Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K.Ayurved Rugnalaya, Department of Shalyatntra, Ground floor OPD No.05, Yavatmal Yavatmal MAHARASHTRA 445001 India
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
7057967672 |
| Fax |
|
| Email |
deshmukhnayana024@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K.Ayurved Rugnalaya, Department of Shalyatntra, Ground floor OPD No.05, Yavatmal
Yavatmal MAHARASHTRA 445001
India |
|
|
Primary Sponsor
|
| Name |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya, Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K.Ayurved Rugnalaya, Department of Shalyatntra, Ground floor OPD No.05, Yavatmal
Yavatmal MAHARASHTRA 445001
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 Nayana Kishor Deshmukh |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya, Department of Shalyatntra, Yavatmal |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K.Ayurved Rugnalaya OPD No.5, Yavatmal
Yavatmal MAHARASHTRA 445001
India
Yavatmal
MAHARASHTRA |
7057967672
deshmukhnayana024@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instutional Ethical Committee Dayabhai Maoji Majithiya yavatmal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K90-K95||Other diseases of the digestive system. Ayurveda Condition: BAGANDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: shunthyadi churna vati, Reference: Su. Chi. 8/38, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Kuleeth kwath), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphala Guggul Vati, Reference: Sha. Madhyam khand 7/ 82-83, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: kuleeth kwath), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Post-operated patients of open fistulectomy of Fistula in Ano.
2) Age group above 18 and below 60 years.
3) Patients willing for a clinical trial, Irrespective of gender, occupation, religion, and economic barriers.
4) Patients with controlled DM and Hypertension.
5 Patients who are willing to give written consent. |
|
| ExclusionCriteria |
| Details |
1 Patients having uncontrolled DM and Hypertension, TB, Ulcerative
colitis, Crohn’s disease, or any malignancy& Immunocompromised
like HIV, HBsAg.
2 Patient on anticoagulant therapy
3 Patients having addictions specifically alcohol, tobacco &smoking. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients suffering from post-operative pain after open fistulectomy in Bhagandara (Fistula in Ano). |
0,3rd,5th,7th,14th,21st,28th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Visual analogue scale
2.tenderness |
0,3rd,5th,7th,14th,21st,28th |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/07/2025 |
| 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="6"
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
|
The current study is randomized controlled clinical to study the efficacy of Shunthyadi Churna Vati in post operative pain management after open fistulectomy in bhagandara ( Fistula in ano). Post operated patients of open fistulectomy will be divided into two equal groups experimental and controlled. The treatment for experimental group is Shunthyadi Churna Vati for 21 days and for controlled group is Triphala Guggul Vati for 21 days. Assessment will be done on 0, 3rd, 5th, 7th, 14th, 21st and 28th day. |