| CTRI Number |
CTRI/2024/10/076085 [Registered on: 30/10/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Kshar sutra application] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of Bhagandar with Yava Kshar sutra and apamarg kshar sutra. |
|
Scientific Title of Study
|
A Comparative clinical study of Yava kshar sutra and Apamarg kshar sutra in the management of Bhagandar with special reference to 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 Dheeraj Soni |
| Designation |
MS Scholar |
| Affiliation |
|
| Address |
OPD. no. 25 department of shalya tantra Rajkiya ayurveda pg college and hospital chaukaghat, varanasi,221002.
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
7879709044 |
| Fax |
|
| Email |
sonidkk2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrigank Shekhar |
| Designation |
Lecturer |
| Affiliation |
Rajkiya ayurveda pg college and hospital chaukaghat, varanasi,221002. |
| Address |
OPD No.25 department of shalya tantra Rajkiya ayurveda pg college and hospital chaukaghat, varanasi,221002.
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9453788863 |
| Fax |
|
| Email |
drmrigank.bhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anubha Srivastav |
| Designation |
Lecturer |
| Affiliation |
Rajkiya ayurveda pg college and hospital chaukaghat, varanasi,221002. |
| Address |
Department of Rachna sharir Rajkiya ayurveda pg college and hospital chaukaghat, varanasi,221002.
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8840712319 |
| Fax |
|
| Email |
hianubha27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd no.25 Government pg ayurveda college and hospital chaukaghat varanasi 221002 |
|
|
Primary Sponsor
|
| Name |
Government pg ayurveda college and hospital varanasi |
| Address |
OPD No, 25 Department of Shalya tantra Rajkeeya ayurveda pg college and hospital chaukaghat varanasi |
| Type of Sponsor |
Government 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 Dheeraj Soni |
Room No.25 Shalya tantra dept. Govt. pg Ayurvedic college and hospital chaukaghat Varanasi |
Room No.25 Shalya tantra department Government pg Ayurvedic college and hospital chaukaghat Varanasi
Varanasi
UTTAR PRADESH |
7879709044
Sonidkk2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC government pg ayurveda college and hospital varanasi u.p mahayogi guru gorakhnath ayush univrsity gorakhpur u.p |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K605||Anorectal fistula. Ayurveda Condition: BAGANDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: चकà¥à¤°à¤¦à¤¤à¥à¤¤ अरà¥à¤¶à¤šà¤¿à¤•à¤¿à¤¤à¥à¤¸à¤¾ ५/१४८., Procedure details: Changing of yava kshar sutra in every 7th day in the application of fistula in ano. )
| | 2 | Comparator Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: चकà¥à¤°à¤¦à¤¤à¥à¤¤ अरà¥à¤¶à¤šà¤¿à¤•à¤¿à¤¤à¥à¤¸à¤¾ ५/१४८., , Procedure details: Snuhi apamarg kshar sutra ligation in fistula in ano followed by changing of kshar sutra in evry 7th day.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient age between 18-60 years
2.Clinical Signs and Symptoms of all types of Bhagandar
3.Both sex( male and female)
|
|
| ExclusionCriteria |
| Details |
1.HBsAg, HCV and HIV positive patients.
2.Secondary fistulas due to:-
i. Crohn’s disease , Ulcerative colitis
ii. Carcinoma of Rectum
iii. Tuberculosis
3.Osteomyelitis of Pelvic Bone.
4.Patient having uncontrolled DM& HTN.
5. Fistula associated with anal fissure and
piles.
6.Pregnancy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Cure of fistula in ano.
|
1.It depends on the length of fistula tract.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Less hospital stay
2.Reduced long time angity.
3.Reduced post operative complication
4.Improved Routine activaty |
3-4 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/12/2024 |
| 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="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
|
Interventional study
Patients suffering from Fistula in ano will be selected from OPD and IPD of Government Ayurvedic college and hospital Varanasi.
Total patients -(60) each groups having 30 patients. Total groups-(2) group-1 (trail group) -patients of fistula in ano ( Bhagandar) will be treated with Arka ksheer based Yavakshar sutra. group-2 (control group)-patients of fistula in ano ( Bhagandar) will be treated with Snuhi ksheer based Apamarga kshar sutra.
Treatment plan-Comparative study of unit cutting time and symptom relief in the patients of fistula in ano with trial group of Yavakshar sutra and Control group of Apamarga kshar sutra.
Treatment duration- it depends on the length of fistulous tract.
Follow up- - 1st follow up - 15 days after the completion of treatment.
- 2nd follow up- 15 days after the 1st follow up.
3rd follow up- 1 month after the 2nd follow up |