| CTRI Number |
CTRI/2021/08/035653 [Registered on: 13/08/2021] Trial Registered Prospectively |
| Last Modified On: |
06/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Babool Apamarga Kshar Sutra in Fistula |
|
Scientific Title of Study
|
EFFECT OF BABOOL APAMARGA KSHAR SUTRA IN BHAGANDARA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAjay Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Rishikul ayurvedic campus haridwar |
| Address |
OPD no 7, department of shalya tantra, Rishikul aurveda college, uttarakhand ayurved university Campus, haridwar
OPD no 7, department of shalya tantra, Rishikul aurveda college, uttarakhand ayurved university Campus, haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9412856414 |
| Fax |
|
| Email |
akg1409@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ayasha Goyal |
| Designation |
Pg scholar |
| Affiliation |
Rishikul ayurvedic campus haridwar |
| Address |
OPD no 7, department of shalya tantra, Rishikul aurveda college, uttarakhand ayurved university Campus, haridwar
OPD no 7, department of shalya tantra, Rishikul aurveda college, uttarakhand ayurved university Campus, haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7895676181 |
| Fax |
|
| Email |
goyalayasha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ayasha Goyal |
| Designation |
Pg scholar |
| Affiliation |
Rishikul ayurvedic campus haridwar |
| Address |
OPD no 7, department of shalya tantra, Rishikul aurveda college, uttarakhand ayurved university Campus, haridwar
OPD no 7, department of shalya tantra, Rishikul aurveda college, uttarakhand ayurved university Campus, haridwar
UTTARANCHAL
249401
India |
| Phone |
7895676181 |
| Fax |
|
| Email |
goyalayasha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul ayurved college and hospital,Haridwar, U.A.U,pin-249401 |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved University |
| Address |
Uttarakhand Ayurved University Railway road Harrawala, Dehradun |
| 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 |
| Ayasha Goyal |
O.P.D and I.P.D of Rishikul Campus, U.A.U, Haridwar |
Department of shalya tantra, Rishikul Ayurveda college and hospital, U.A.U
Hardwar
UTTARANCHAL |
7895676181
goyalayasha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee uttarakhand ayurved university |
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: BAGANDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Babool Apamarga Kshar Sutra | (Procedure Reference: Chakradutta, Procedure details: 33 patients will be applied Babool Apamarga Kshar Sutra asper classical method Route- Anorectal and perianal region Duration-According to the length of fistula track)
|
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Clinical Signs and Symptoms of all types of Bhagandara |
|
| ExclusionCriteria |
| Details |
Patient with Malignancy (Anus, Rectum, Prostate)
HIV, HCV, HBsAg positive patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Itching (Mild, Moderate, Severe, Very Severe)
Pain (Mild, Moderate, Severe, Very Severe)
Burning Sensation (Mild, Moderate, Severe, Very Severe)
Discharge (Mild, Moderate, Severe, Very Severe) |
Kshar sutra will be changed after 7 days & assessment will be saught in every 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Exacerbations in signs and symptoms |
It will depend on the length of fistula tract up to,maximum twelve months |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2021 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Bhagandar(fistula in ano)isone of the most common Ano-, rectal disese in our countary. Surgical treatments of fistula in ano has reported high recurrence rate. In Ayrveda Kshra sutra therapy for management of Bhagandara is simple and safe para surgical procedure.It is cost effective, complication free and negligible recurrence rate. AIMS AND OBJECTIVES
1. To evaluate the the Effect of Babool-Apamarga Kshara sutra in Bhagandara. 2. To decrease the intensity of pain, burning sensation and itching, so that the patient can do his routine works comfortably. |