| CTRI Number |
CTRI/2024/06/068947 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Application of Ksharsutra and Ksharsutra with Trivratyadi Taila in bhagandar |
|
Scientific Title of Study
|
Clinical comparative study to evaluate the efficacy of IFTAK procedure and application of trivratyadi taila after IFTAK procedure in the management of bhagandar(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 Maninder Singh Sisodiya |
| Designation |
MS Scholar |
| Affiliation |
Post Graduate Institute Of Ayurved Jodhpur Rajasthan |
| Address |
P G Department Of shalya tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Ayurved University Jodhpur
Rajasthan
Jodhpur
RAJASTHAN
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8502812856 |
| Fax |
|
| Email |
mss91096@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maninder Singh Sisodiya |
| Designation |
MS Scholar |
| Affiliation |
Post Graduate Institute Of Ayurved Jodhpur Rajasthan |
| Address |
P G Department Of shalya tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Ayurved University Jodhpur
Rajasthan
Jodhpur
RAJASTHAN
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8502812856 |
| Fax |
|
| Email |
mss91096@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Rajesh Kumar Gupta |
| Designation |
Professor and HOD |
| Affiliation |
Post Graduate Institute Of Ayurved Jodhpur Rajasthan |
| Address |
P G Department Of shalya tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Ayurved University Jodhpur
Rajasthan
Jodhpur
RAJASTHAN
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636520573 |
| Fax |
|
| Email |
guptadrrajeshkumargupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute Of Ayurved Jodhpur Rajasthan INDIA 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute Of Ayurved Jodhpur Rajasthan |
| Address |
P G Department Of shalya tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Ayurved University Jodhpur
Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| 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 Maninder Singh Sisodiya |
Sanjeevani hospital Post Graduate Institute of Ayurveda |
Shalya OPD 14
P G Department Of
Shalya tantra Post
Graduate Institute of
Ayurved Dr Sarvepalli
Radhakrishnan Ayurved
University Jodhpur
RAJASTHAN 342037
India
Jodhpur
RAJASTHAN |
8502812856
mss91096@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Post Graduate Institute of Ayurved Jodhpur |
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 | Comparator Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: M Sahu A Sharma Management of complex fistula in ano by interception of fistula track with application of Ksharasutra , Procedure details: In IFTAK procedure there is a interception of fistulous tract by creating a window opening at 6 o clock position and application of ksharsutra through window)
| | 2 | Intervention Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: M Sahu A Sharma Management of complex fistula in ano by interception of fistula track with application of Ksharasutra , Procedure details: In IFTAK procedure there is a interception of fistulous tract by creating a window opening at 6 o clock position and application of ksharsutra through window
After IFTAK procedure under all aseptic precaution Trivratyadi Taila taken in 5 ml syringe
use to draw for Taila Pooran and instilled through syringe into Bhagandar slowly followed
by packing with gauze piece and dressing)
(1) Medicine Name: Trivratyadi Taila, Reference: Sushruta Chikitsa Chapter 8 Shloka 48 49, Route: Rectal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 1 Months |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Blind fistula in ano.
2. Low anal fistula in ano.
3. All type tract of Crypto glandular fistula in ano
4. Recurrent fistula in ano.
5. Complex fistula in ano.
|
|
| ExclusionCriteria |
| Details |
1. Bhagandara present with tuberculosis.
2. Regional Ileitis
3. Any malignancies related with fistula in ano.
4. Chronic/acute ulcerative Colitis.
5. HIV& HbsAg Positive patient.
6. Crohn’s disease
7. Fecal Fistula & Uretero-Vaginal Fistula
8. Non-Crypto glandular Fistula in ano
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical efficacy of application of Trivratyadi Taila after IFTAK procedure compared to only IFTAK procedure in the management of Bhagandar fistula in ano |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To understand the IFTAK procedure & to rule out the efficacy of application of Trivratyadi Taila after IFTAK in management of Bhagandar |
60 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/06/2024 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Study Type : Interventional , comparative clinical study Sample size : 40(20 patients in each group) 40 patients fulfilling the inclusion criteria are fit for the study, should be randomly selected:
Group A- IFTAK procedure is done by interception of fistulous tract by creating a window opening at 6 o’clock position and application of ksharsutra through window. Group B- IFTAK procedure is done same as group A with application of Trivratyadi Taila 5 ml for Taila Pooran in Fistulous tract slowly under all aseptic precaution. Duration of study : 2 Months Follow up – weekly after finishing the trial treatment protocol period |