| CTRI Number |
CTRI/2021/07/035020 [Registered on: 20/07/2021] Trial Registered Prospectively |
| Last Modified On: |
11/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see the effect of Guggulu-Nimb Kshar sutra and Saptang Guggulu in Bhagandara (Fistula in ano) |
|
Scientific Title of Study
|
Evaluation Of Guggulu–Nimb Kshar Sutra Ligation With Saptang Guggulu Oraly In Bhagandara (Fistula-In-Ano) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prem Prakash Rai |
| Designation |
PG Scholar |
| Affiliation |
Patanjali bhartiya ayurvigyan evam anusandhan sansthan |
| Address |
PG Department Of Shalya Tantra
Patanjali Ayurveda
Hospital
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7060197273 |
| Fax |
|
| Email |
pprai333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prem Prakash Rai |
| Designation |
PG Scholar |
| Affiliation |
Patanjali bhartiya ayurvigyan evam anusandhan sansthan |
| Address |
PG Department Of Shalya Tantra
Patanjali Ayurveda
Hospital
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7060197273 |
| Fax |
|
| Email |
pprai333@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Gupta |
| Designation |
Professor and HOD |
| Affiliation |
Patanjali Ayurvedic Hospital |
| Address |
Opd no. 15, shalya tantra department,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9419135050 |
| Fax |
|
| Email |
chintu.925@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Ayurvedic Hospital |
|
|
Primary Sponsor
|
| Name |
Patanjali Aayurvedic College |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
| 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 Prem Prakash Rai |
Patanjali Ayurvedic Hospital |
opd no 15 dept of
shalya tantra ,
Patanjali ayurvedic college and hospital, haridwar
Hardwar
UTTARANCHAL |
7060197273
pprai333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee patanjali ayurvedic college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K603||Anal fistula. Ayurveda Condition: BAGANDARAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guggulu - Nimb Kshar Sutra ligation |
Guggulu - Nimb Kshar Sutra ligation till the disappearance of fistula in ano |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Saptang Guggulu 1 gram BD oraly |
Saptang Guggulu 2 tab BD (500mg each) oraly after meal with lukewarm water for 3 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinical Signs and Symptoms of all types of Bhagandara |
|
| ExclusionCriteria |
| Details |
HBsAg, HCV and HIV positive patients.
Secondary fistula due to/along with:
1-Ulcerative colitis
2- Osteomyelitis of pelvic bones
3-Crohn’s disease
4-Tuberculosis
5-Uncontrolled Diabetes
6- Pelvic abscess
7-Carcinoma of rectum
8. Hemorrhoids
9- Fissure-in-ano
10- Other systemic disorders. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective Parameters -
Pain
Discharge
Inflammation
Itching
Burning sensation
Objective Parameters
Unite Cutting time |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective Parameters -
Pain
Discharge
Inflammation
Itching
Burning sensation
Objective Parameters
Unite Cutting time |
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
23/07/2021 |
| Date of Study Completion (India) |
15/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In this trail , we were selected patients of Bhagandara (Fistula in ano) in which we hav done the intervention with Guggulu Kshar Sutra ligation procedure in fistulous tract and Saptang Guggulu oraly 2 tab BD (500 mg each) till the disappearance of fistula in ano. Assessment was done on the basis of subjective and objective parameters. Subjective parameters includes pain, discharge, inflammation, itching, burning sensation and objectives parameters include Unite Cutting time. Result shows that guggulu nimba kshar sutra application along with oral use of saptang guggulu is effective in the treatment of Bhagandara. |