| CTRI Number |
CTRI/2023/06/054040 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
11/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Para- surgical ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of Fistula-in-Ano using Guggulu Apamarga Kshara-Sutra & Guggulu Karvira Kshara-Sutra |
|
Scientific Title of Study
|
A Comparative Clinical Study of Guggulu Apamarga Kshara-Sutra & Guggulu Karvira Kshara-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 |
Dr Ajay Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University, Haridwar |
| Address |
OPD No-7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University Haridwar Uttarakhand 249401 India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9412856414 |
| Fax |
|
| Email |
akg1409@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University, Haridwar |
| Address |
OPD No-7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University Haridwar Uttarakhand 249401 India
UTTARANCHAL
249401
India |
| Phone |
9412856414 |
| Fax |
|
| Email |
akg1409@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Basant Mohan Negi |
| Designation |
PG Scholar |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University, Haridwar |
| Address |
OPD No-7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University Haridwar Uttarakhand 249401 India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7351763096 |
| Fax |
|
| Email |
basantnegi1@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No-7, Rishikul Campus, Haridwar |
|
|
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 |
| Dr Basant Mohan Negi |
Rishikul Campus, Haridwar |
OPD No-7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University Haridwar Uttarakhand 249401 India
Hardwar
UTTARANCHAL |
7351763096
basantnegi1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Uttarakhand Ayurved University, Rishikul Campus, Haridwar |
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: Chakradutta Arshodhikar, Procedure details: Guggulu Karvira Kshara-Sutra will be ligated in fistula-in-ano and it will be changed every 7 days until it heals completely)
| | 2 | Comparator Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: Chakradutta Arshodhikar, Procedure details: Guggulu Apamarga Kshara-Sutra will be ligated in fistula-in-ano and it will be changed every 7 days until it heals completely)
|
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Clinical signs and symptoms of all types of Bhagandara |
|
| ExclusionCriteria |
| Details |
01.Known Patient with Malignancy of Anus, Rectum, Prostate
02.HIV, HCV and HBsAg positive patients
03.Covid-19 positive patients
04.Secondary fistula due to Crohns disease, Ulcerative colitis, Tuberculosis etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome will be measured with the parameters-
01.Pain
02.Burning sensation
03.Itching
04.Discharge
05.Unit cutting time |
It will be assessed every 7th day(weekly), Until
fistula track heals completely |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| unit cutting time |
It will be assessed every 7th day(weekly), Until
fistula track heals completely |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
22/06/2023 |
| 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
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The disease causing Darana of Bhaga , Guda and Basti Pradesha is known as Bhagandara. In apakvaavastha it is known as Pidika whereas in Pakvavastha it is called Bhagandara. A Fistula-in-ano or Anal fistula, is a chronic abnormal communication, usually lined to some degree by granulation tissue, which runs outward from the anorectal lumen to an external opening on the skin of the perineum or buttock. Kshara Sutra Therapy is a minimally invasive Ayurvedic Parasurgical procedure and time-tested Ayurvedic technique in the management of Anorectal disorders. It is a safe, sure and cost effective method of treatment for Fistula-in-ano, Haemorrhoids and other sinus diseases.
Aim and objectives are-
1. To evaluate the effect of Guggulu Apamarga Kshara-Sutra in Bhagandara. 2. To evaluate the effect of Guggulu Karvira Kshara-Sutra in Bhagandara. 3. To compare the effect of both these Kshara-Sutra in the treatment of two different groups of patients of Bhagandara. 4. To enhance the rate of healing.
|