| CTRI Number |
CTRI/2020/05/025140 [Registered on: 13/05/2020] Trial Registered Prospectively |
| Last Modified On: |
27/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Medicated Thread in The Management Of Bhagandara (Fistula -In-Ano) |
|
Scientific Title of Study
|
A Clinical Evaluation of Snuhi Ksharasutra In The Management of 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 Rohitash Gurjar |
| Designation |
PG Scholar |
| Affiliation |
National institute of Ayurveda |
| Address |
Department of Shalya Tantra, National Institute of Ayurveda, Near Jorawar singh gate,Amer road,Jaipur.
Jaipur
RAJASTHAN
302002
India |
| Phone |
9785414287 |
| Fax |
|
| Email |
rohitgurjar080@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Sanjeev sharma |
| Designation |
Director, National Institute of Ayurveda |
| Affiliation |
National institute of Ayurveda |
| Address |
Department of Shalya tantra, National Institute of Ayurveda, Near Jorawar singh gate,Amer road,Jaipur.
Jaipur
RAJASTHAN
302002
India |
| Phone |
9418079691 |
| Fax |
|
| Email |
Profsanjeevhp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Sanjeev sharma |
| Designation |
Director, National Institute of Ayurveda |
| Affiliation |
National institute of Ayurveda |
| Address |
Department of Shalya tantra, National Institute of Ayurveda, Near Jorawar singh gate,Amer road,Jaipur.
Jaipur
RAJASTHAN
302002
India |
| Phone |
9418079691 |
| Fax |
|
| Email |
Profsanjeevhp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalya tantra, National Institute of Ayurveda, Near Jorawar singh gate,Amer road,Jaipur,rjasthan 302002 |
|
|
Primary Sponsor
|
| Name |
National institute of Ayurveda |
| Address |
Department of Shalya Tantra, National Institute of Ayurveda, Near Jorawar singh gate,Amer road,Jaipur. |
| 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 Rohitash Gurjar |
National Institute of Ayurveda, Jaipur. |
Department of Shalya Tantra, National Institute of Ayurveda, Near Jorawar singh gate,Amer road,Jaipur.
Jaipur
RAJASTHAN |
9785414287
rohitgurjar080@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Apamarga ksharasutra |
Group-A this group will be treated with standard apamarga ksharasutra ( control group)
Apamarga ksarasutra will be changed every week for 3 month or complete cut through of fistulus track. |
| Intervention |
Snuhi ksharasutra |
Group B- This group will be treated with Snuhi Ká¹£arasutra (Trial group).
Snuhi ksarasutra will changed every week for 3 month or complete cut through of fistulus track |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female between age 18 to 60 years and willing to give their written Informed consent.
2.No major systemic disease involved.
3. Patients who have signs and symptoms of Bhagandara (fistula-in-ano).
|
|
| ExclusionCriteria |
| Details |
1. Male or female less than 18 years and greater than 60 years of age.
2. Patient with known hypersensitivity to any of the components of the formulation.
3. Bhagandara (Fistula-in-ano) associated with one or more of the following conditions:-
A. Ulcerative Colitis
B. Uncontrolled Hypertension
C. Uncontrolled Diabetes Mellitus
D. Veneral diseases
E. HIV and Hepatitis B,C patients
F. Crohn’s disease
G. Fistula other than ano-rectal area.
H. All other secondary Fistulae-in-ano.
I. Supra Levator Fistula.
J.CA Rectum
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Snuhi Ksharasutra with standard Apamarga Ksharasutra in the management of Bhagandara. |
12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Snuhi Ksharasutra in the management of Bhagandara.
To perform Phytochemical analysis of prepared Snuhi Kshara
Protocol development for Eto sterilization of prepared kshara sutra.
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/05/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ksharasutra is
routinely prepared with Snuhi Kshira, Apamarga Kshara and Haridra
Churna. It is known as standard Apamarga Ksharasutra and is known
device for the treatment of Fistula-in-ano and has been standardized by the
Department of Shalya/Shalakya, Banaras Hindu University, Varanasi
and the CCRAS. Since we cannot depend always on single type of Ksharasutra
and there is a need to explore other drugs which can be used in the preparation
of Ksharasutra in accordance with the references made by our Acharyas
at different places in their treatises.
India is a vast country with varied
flora so there is a need to search for an alternate plants which can play a
better role in the preparation of Ksharasutra in terms of efficacy. Snuhi
can be a better alternative if proved efficient in the proposed study which has
a special mention in the Sushruta Samhita because no studies have
been carried out on this drug in the management of Bhagandara, therefore
there is a need to evaluate its efficacy.
Acharya Sushruta
has mentioned in the Sushruta Samhita Sutra Sthana chapter 11 verse 12 (Ksharapakavidhiadhyaya)
about the Snuhi as one of the plants which can be used in the
preparation of Kshara which is Tikshna Virechana, lekhna, Shoolhar,
Shothahar, Raktashodhana And Stambhana. Snuhi is
abundantly and easily available and its preservation for longer periods is
easier. |