| CTRI Number |
CTRI/2025/03/081707 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A comparative study on the effect of Nishadi sutra against Apamarga ksharasutra in Bhagandara.
|
|
Scientific Title of Study
|
A comparative clinical study on the Effectiveness of Nishadi sutra against Apamarga ksharasutra in Bhagandara.
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaisali K S |
| Designation |
PG SCHOLAR ,DEPARTMENT OF SALYATANTRA |
| Affiliation |
Government Ayurveda College,Trippunithura. |
| Address |
Vaisali K S
Pg Scholar Department of Salyatantra,Government Ayurveda College,Trippunithura.
Ernakulam
KERALA
682301
India |
| Phone |
9447608599 |
| Fax |
|
| Email |
vaisalisuresh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Jose |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Thrippunithura |
| Address |
Dr.Deepa Jose
Associate Professor,
Department Of Salyatantra, Government Ayurveda College Trippunithura,Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9446864399 |
| Fax |
|
| Email |
jodrdeepa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa Jose |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Trippunithura ,Ernakulam |
| Address |
Dr.Deepa Jose
Associate Professor,Department of Salyatantra,
Government Ayurveda College Trippunithura,Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9446864399 |
| Fax |
|
| Email |
jodrdeepa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Trippunithura |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College Thrippunithura |
| Address |
Government Ayurveda College Hospital Triippunithura,Ernakulam,682301 |
| 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 |
| DrVaisali K S |
Government Ayurveda College Hospital Trippunithura |
Dr.Vaisali KS ,
Department of Salyatantra,Government Ayurveda College Hospital ,Puthiyakavu,Trippunithura,Pin-682301
Ernakulam
KERALA |
09447608599
vaisalisuresh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ,Government Ayurveda College Trippunithura,Kochi,Kerala |
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 | Drug | Classical | | (1) Medicine Name: NISHADI LEPAM , Reference: BASAVARAJEEYAM, Route: Rectal, Dosage Form: Kalka/ Paste , Dose: 1(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Years, anupAna/sahapAna: No, Additional Information: Guggulu,Sweta sarshap,Madhu,Saindhavam,Haridra are the drugs |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Low anal fistula diagnosed by clinical examination
Participants with age group of 18-60 years
Participants with informed written consent |
|
| ExclusionCriteria |
| Details |
Fistula associated with Ulcerative Colitis, Crohn’s disease,
Colorectal carcinoma, Tuberculosis.
Fistula in participants with HIV, Hepatitis B or Veneral diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Unit cutting time- assessed by weekly measurement of sutra length
2. Reduction in pain(VAS scale)
3.Reduction in burning sensation assessed through grading. |
assessed properly on its change on 7th day. Later on, all outcome variables will be assessed weekly on 7th, 14th, 21st,28th, 35th, 42nd, 49th, 56th, 63rd, 70th,77th and 84th days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in pain(VAS scale)
Reduction in burning sensation assessed through grading. |
Other variables will be assessed weekly on 7th, 14th, 21st,28th, 35th, 42nd, 49th, 56th, 63rd, 70th,77th and 84th days. |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
17/03/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study Nishadi sutra mentioned in Basavarajeeyam is compared with Apamarga ksharasuthra, the standard one, in its cutting effect along with pain and burning sensation. 46 participants,selected from the OPD and IPD of Salyatantra, Government Ayurveda College Hospital, Tripunithura satisfying the inclusion and exclusion criteria will be allocated to both trial and control group .Nishadi sutra is applied in the study group and Apamarga ksharasutra in the control group. Assessment of cutting effect is done by calculating Unit cutting time(UCT) . Length of thread is measured on every 7 th day during thread change. Assessment of pain, burning sensation will be based on the Visual Analogue Scale and grading by Paul O Madson and Peter respectively and both are assessed from the first day of application and on every 7th day of thread change. The observations thus obtained will be analysed using a suitable statistical method.
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