| CTRI Number |
CTRI/2024/02/062969 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
15/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of 2 ksharasutra, Tankana ksharasutra and Nimba ksharasutra in patient with Bhagandara(Fistula in ano) |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Tankana ksharasutra and Nimba ksharasutra in the management of Bhagandara Vis-a-vis 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 Hapani Uttamkumar Vitthalbhai |
| Designation |
PG scholar |
| Affiliation |
Ayurveda Mahavidyalaya and Hospital Hubbali |
| Address |
Room no 17, Department of PG and PhD studies in Shalya Tantra
Ayurveda Mahavidyalaya and Hospital, Heggeri
extension, Old Hubli, Hubballi Heggeri extension, Old Hubli, Hubballi
580024
Dharwad
KARNATAKA
580024
India |
| Phone |
9513237392 |
| Fax |
122 |
| Email |
uvhapani98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabhakar Taseen |
| Designation |
Professor |
| Affiliation |
Ayurveda Mahavidyalaya and Hospital Hubbali |
| Address |
Department of PG and PhD studies in Shalya Tantra, Ayurveda
Mahavidyalaya and Hospital, Hubballi Heggeri extension, Old Hubli,
Hubballi 580024
Dharwad
KARNATAKA
580024
India |
| Phone |
9844765647 |
| Fax |
122 |
| Email |
tasinph@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hapani Uttamkumar Vitthalbhai |
| Designation |
PG scholar |
| Affiliation |
Ayurveda Mahavidyalaya and Hospital Hubbali |
| Address |
Room No - 17, Department of PG and PhD studies in Shalya Tantra,
Ayurveda Mahavidyalaya and Hospital, Hubballi Heggeri extension,
Old Hubli, Hubballi 580024
Dharwad
KARNATAKA
580024
India |
| Phone |
9513237392 |
| Fax |
122 |
| Email |
uvhapani98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurveda Mahavidyalaya and Hospital, Old hubballi, Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Hapani Uttamkumar Vitthalbhai |
| Address |
Ayurveda mahavidyalaya and Hospital, Old hubballi, Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
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 Hapani Uttamkumar Vitthalbhai |
Ayurveda Mahavidyalaya and Hospital, hubli, Karnataka |
Room no.17 Department of shalya tantra, Ayurveda mahavidyalaya and Hospital, Old hubballi, Karnataka
Dharwad
KARNATAKA |
9513237392
122
uvhapani98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayurveda Mahavidyalaya and Hospital Hubballi |
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 | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: Sushruta samhita, chikitsa sthana , Procedure details:
Pradhanakarma:
Subject will be made to lie down in a lithotomy position. Perianal region will be painted with aseptic solution and draped.
Inj.Xylocaine 2% will be infiltrated around the fistulous tract.
Probing will be done through external opening to assess length and direction of tract. Lubricated finger inserted in anal canal to feel the tip of the probe.
Tankana Ksharasutra will be ligated with the help of probe.
Gauze dipped in jatyadi taila will be kept and bandaging will be don)
(1) Medicine Name: Swadishtavirechana churna, Reference: Bhaishajya sarasamgraha, churna prakarana, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: hs, Duration: 30 Days(2) Medicine Name: Gandhaka Rasayana , Reference: Rasa tarangini,8/81-86, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: Sushruta samhita, chikitsa sthana , Procedure details:
Pradhanakarma:
Subject will be made to lie down in a lithotomy position. Perianal region will be painted with aseptic solution and draped.
Inj.Xylocaine 2% will be infiltrated around the fistulous tract.
Probing will be done through external opening to assess length and direction of tract. Lubricated finger inserted in anal canal to feel the tip of the probe.
Nimba Ksharasutra will be ligated with the help of probe.
Gauze dipped in jatyadi taila will be kept and bandaging will be done.)
(1) Medicine Name: Swadishta virechana churna , Reference: Bhaishajya sarasamgraha, churna prakarana , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: hs, Duration: 30 Days(2) Medicine Name: Gandhaka Rasayana , Reference: Rasa tarangini, 8/81-86, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subject with signs and symptoms of Bhagandara
2.Subject with low anal fistula.
3.Subject of fistula in ano with systemic diseases like Diabetes mellitus and Hypertension which are under control.
4.Subject fit for Ksharasutra.
|
|
| ExclusionCriteria |
| Details |
1.Subject having high anal fistula and multiple tracts.
2.Subject with acute or chronic ulcerative colitis, crohn’s disease, Fistula secondary to tuberculosis.
3.Subject associated with uncontrolled Hypertension/Diabetes mellitus, Anaemia, Cardiac disorders, and Malignancy.
4.Subject with Hepatitis B, HIV and VDRL Positive cases.
5.Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Unit cutting time (UCT)8 days/cm |
At baseline, 1st week,2nd week,3rd week, 4th week,5th week till complete cutting of the fistula tract within 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Objective & Subjective criteria Reduction in pain, pus discharge, itching, unit cutting time less than 2 |
Less than 2 |
|
|
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 |
|
Date of First Enrollment (India)
|
26/02/2024 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [uvhapani98@gmail.com].
- For how long will this data be available start date provided 29-01-2024 and end date provided 29-01-3851?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomized, open label, parallel group,active controlled trial comparing the efficacy
of Tankana Ksharasutra (type of medicated Seton with processed borex) and Nimba Ksharasutra
(Medicated Seton with processed azadiracta indica) tied in uncomplicated fistula tract, and
changing these Ksharasutra after 7th day till the complete cutting and healing of the tract
meanwhile assessing the pain, pus discharge, itching per anum every 7th day. Cutting and healing
of the tract will be assessed by Unit cutting time (UCT) i.e time taken in days to cut 1 cm of the
fistula tract. Patients with uncontrolled Dm, HTN, TB and multiple fistulas tract are excluded.
Primary outcome of the proposal is to have UCT less than 8 days/cm. Which will be calculated by
based on overall duration of treatment within 1 yea |