| CTRI Number |
CTRI/2026/04/107829 [Registered on: 07/04/2026] Trial Registered Prospectively |
| Last Modified On: |
04/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomized Controlled Clinical Study To Evaluate The Efficacy Of Papaya-nimba Ksharsutra In The Management Of
Bhagandara W.S.R.Fistula In Ano |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial To Evaluate The Efficacy Of Papaya-nimba Ksharsutra In The Management Of
Bhagandara W.S.R.Fistula In Ano |
| 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. Vaishnavi Manohar Nagpure |
| Designation |
PG SCHOLAR |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya Amravati |
| Address |
OPD No. 22 Department Of Shalyatantra Vidarbha Ayurved Mahavidyalaya Amravati Maharashtra 444605
OPD No 22 Department Of Shalyatantra Vidarbha Ayurved Mahavidyalaya Amravati 44605
Amravati
MAHARASHTRA
444605
India |
| Phone |
9579715064 |
| Fax |
|
| Email |
vaishnavinagpure1404@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjusha S. Kalmegh |
| Designation |
Guide and HOD Department of Shalyatantra |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya Amravati |
| Address |
OPD No 22 Department Of Shalyatantra Vidarbha Ayurved Mahavidyalaya Amravati Maharashtra 444605 India
OPD No 22 Department of Shalyatantra Vidarbha Ayurved Mahavidyalaya Amravati Maharashtra 444605
Amravati
MAHARASHTRA
444605
India |
| Phone |
09518390211 |
| Fax |
|
| Email |
manjushakalmegh75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishnavi Manohar Nagpure |
| Designation |
PG Scholar Shalyatantra Department |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya Amravati |
| Address |
OPD No 22 Department Of Shalyatantra Vidarbha Ayurved Mahavidyalaya Amravati Maharashtra 444605 India
OPD No 22 Department Of Shalyatantra Vidarbha Ayurved Mahavidyalaya Amravati 444605
Amravati
MAHARASHTRA
444605
India |
| Phone |
9579715064 |
| Fax |
|
| Email |
vaishnavinagpure1404@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No 22 ,Department Of Shalyatantra,Vidarbha Ayurved Mahavidyalaya Amravati Maharashtra 444605 |
|
|
Primary Sponsor
|
| Name |
Dr Vaishnavi Manohar Nagpure |
| Address |
Vidarbha Ayurved Mahavidyalaya Amravati Dhanvantari Nagar Amravati Maharashtra 444605 |
| 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 Vaishnavi Manohar Nagpure |
vidarbha ayurved mahavidyalaya Amravati |
OPD No 22 Department Of Shalyatantra Vidarbha Ayurved Mahavidyalaya Amravati
Maharashtra 444605 India
OPD NO 22 SHALYATANTRA DEPARTMENT V.A.M. AMRAVATI
Amravati
MAHARASHTRA |
09579715064
vaishnavinagpure1404@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Of Vidarbha Ayurved Mahavidyalaya Amravati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: BAGAN, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kShArasUtra, क्षारसूत्र | (Procedure Reference: chakrapanidatta. Chakradatta, Chapter 5,Verse 148. In: Tripathi l, editor. Varanasi:Chaukhambha Sanskrit Series Office; 2007 , Procedure details: papaya-nimba ksharsutra application in the patient of bhagandara once a week for 45 days), Procedure details: )
| | 2 | Intervention Arm | Procedure | - | kShArasUtra, क्षारसूत्र | (Procedure Reference: Procedure Reference: chakrapanidatta. Chakradatta, Chapter 5,Verse 148. In: Tripathi l, editor. Varanasi:Chaukhambha Sanskrit Series Office; 2007 , Procedure details: Procedure details: papaya-nimba ksharsutra application in the patient of bhagandara once a week for 45 days), Procedure details: ))
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with signs and symptoms of bhagandara W.S.R. fistula in ano 2.simple low anal fistula 3.fistula tract length upto 5 cm 4.Patients irrespective to gender cast religion and economic status |
|
| ExclusionCriteria |
| Details |
1.Indivisuals with HIV and HBSAG positive
2.Patients with uncontrolled DM and asthma
3. The development of fistula as a result of illness such as cancer crohns disease IBD ulcerative colitis tuberculosis
4.fistula with multiple tracts |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assesment will be done based on subjective criteria
grade will be given from 0 to 3 for pain discharge nature of discharge itching swelling
obective criteria unit cutting time |
Assessment will be done on baseline ,7th day,14th day,21th day,28th day,35th day,45 Thank day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
17/04/2026 |
| 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
|
Title -“A Randomized Controlled Clinical Trial To Evaluate The Efficacy Of Papaya-Nimba
Ksharsutra In The Management Of Bhagandara W.S.R Fistula in Ano ”Type of Study Design: -
Randomized Controlled Clinical Trial Primary objective To evaluate the effectiveness of papaya- nimbaksharsutra in the management of
bhagandara W.S.R Fistula in ano in comparison with standard snuhi-apamarga
ksharsutra Secondary objective 1)To propose an alternative easily available medicated ksharsutra in the
management of bhagandara 2)To evaluate the pain and discomfort during and after procedure between the
two groups 3)To evaluate the effect of papaya-nimbaksharsutra on wound healing time 4)To asscess the reduction in pain , discharge, and itching during treatment
7 A} Inclusion Criteria-
1) Subjects having signs and symptoms of bhagandara W.S.R. Fistula in ano
2) Simple low anal fistula
3) Patients between the ages of 18 and 60
4) Fistula Track Length Up to 5 cm
5) Patient irrespective to gender ,cast religion, or economic status B] EXCLUSION CRITERIA:
1. Individuals with HIV and HBsAg positive
2. Patients with uncontrolled diabetes and asthma 3. The development of fistula as a result of illnesses such as cancer, Crohn’s
disease, IBD, ulcerative colitis, and tuberculosis
4. Fistula with Multiple Tracks |