| CTRI Number |
CTRI/2024/10/075847 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
19/10/2024 |
| 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
|
To do a Comparative Study of the effect of Apamarga Ksharsutra and Shigru Guggulu Ksharsutra in the Treatment of Fistula in Ano |
|
Scientific Title of Study
|
A Comparative Study of the Efficacy of Apamarga Ksharsutra and Shigru Guggulu Ksharsutra in the Management of 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 Meenakshi |
| Designation |
PhD Scholar |
| Affiliation |
Shri Krishna AYUSH University Kurukshetra, Haryana |
| Address |
Dept of Shalya Tantra, Institute for Ayurved Studies and Research , Faculty of Ayurved, Shri Krishna AYUSH University, Umri Road, Sector 8
Kurukshetra
HARYANA
136118
India |
| Phone |
9540274040 |
| Fax |
|
| Email |
mailmee88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajender Singh |
| Designation |
Associate Professor & Chairperson |
| Affiliation |
Shri Krishna AYUSH University Kurukshetra, Haryana |
| Address |
Dept of Shalya Tantra, Institute for Ayurved Studies and Research , Faculty of Ayurved, Shri Krishna AYUSH University, Umri Road, Sector 8
Kurukshetra
HARYANA
136118
India |
| Phone |
9416662761 |
| Fax |
|
| Email |
drrajendersingh1346@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anamika |
| Designation |
Assistant Professor Shalya Tantra |
| Affiliation |
Shri Krishna AYUSH University Kurukshetra, Haryana |
| Address |
Dept of Shalya Tantra, Institute for Ayurved Studies and Research , Faculty of Ayurved, Shri Krishna AYUSH University, Umri Road, Sector 8
Kurukshetra
HARYANA
136118
India |
| Phone |
9896873083 |
| Fax |
|
| Email |
dranamikashalyavida@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research , Faculty of Ayurved, Shri Krishna AYUSH University, Umri Road, Sector 8, Kurukshetra, Haryana, 136118 |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research , Faculty of Ayurved, Shri Krishna AYUSH University |
| Address |
Umri Road, Sector 8, Kurukshetra, Haryana, 136118 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre |
Adarsh Vijendra Marg, Gangoh, Saharanpur Uttar Pradesh, 247341 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Narendra Singh Shekhawat |
Kunwar Shekhar Vijendra Ayurved Hospital and Research Centre |
Babu Vijendra Marg, Shobhit University, Gangoh
Saharanpur
UTTAR PRADESH |
9928297691
dr.naren90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Shri Krishna AYUSH University |
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Shigru Guggulu Ksharsutra | (Procedure Reference: Raj Nighantu, Procedure details: Guggulu Based Shigru Ksharsutra is prepared by Shigru Kshar, Guggulu & Haridra. 21 layered Ksharsutra is made. It will be externally used as an Anushashtra. Ksharsutra will be ligated by using IFTAK TECHNIQUE on day Zero & changed after every seven days up to four weeks. Follow up will be taken at the end of 6th & 7th weeks.)
| | 2 | Comparator Arm | Procedure | - | Apamarga kShArasUtra | (Procedure Reference: Chakradatta, Procedure details: Apamarga Ksharsutra is prepared by Apamarga Kshar, Snuhi Ksheer & Haridra. 21 layered Ksharsutra is made. It will be externally used as an Anushashtra. Ksharsutra will be ligated by using IFTAK TECHNIQUE. on day Zero & changed after every seven days up to four weeks. Follow up will be taken at the end of 6th & 7th weeks.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All types of Low anal Fistula |
|
| ExclusionCriteria |
| Details |
Patient having Fistula in ano with Tuberculosis, Regional Ileitis, Malignancy, Acute/Chronic Ulcerative colitis, HbsAg - HIV Positive, Crohn Diseases, Faecal Fistula, Ureterovaginal Fistula, Noncryptoglandular fistula in ano |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Vedana (Pain in perianal area)
2. Srava (Pus discharge from perianal area).
3. Shotha (Swelling)
4. Kandu (Itching).
|
zero day, 7th day, 14th day, 21th day, 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Unit Cutting Time |
zero day, 7th day, 14th day, 21th day, 28th day |
|
|
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 2 |
|
Date of First Enrollment (India)
|
04/11/2024 |
| 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="0"
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
|
This study is a randomized, parallel group, active controlled trail comparing the efficacy of Apamarga Ksharsutra and Shigru Guggulu Ksharrsutra for 1 year in 120 patients with fistula in ano. The primary outcome measures will be relief in vedana, shotha, srava and kandu. The secondary measure will be decrease in the treatment time for fistula in ano. |