| CTRI Number |
CTRI/2025/04/085430 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [nil] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Nyagrodh Tail Pooran in Bhagandara with Special Refernce Fistula in Ano |
|
Scientific Title of Study
|
A Randomized Controlled Trial On Effect Of Nyagrodh Tail Pooran And Standard Ksharsutra In The Bhagandara With Special Reference To 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 |
Khedkar Sonali Jagdish |
| Designation |
PG Scolar |
| Affiliation |
Government Ayurveda College And Hospital , Nagpur |
| Address |
Department Of Shalyatantra OPD No.3 At Government Ayurveda College and Hospital Sakkardara Square Nagpur MAHARASHTRA 440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9834564082 |
| Fax |
|
| Email |
sonalikhedkar33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nita Kedar |
| Designation |
HOD and Professor |
| Affiliation |
Government Ayurveda College And Hospital , Nagpur |
| Address |
Department Of Shalyatantra OPD No.3 At Government Ayurveda College and Hospital Sakkardara Square Nagpur MAHARASHTRA 440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9422117613 |
| Fax |
|
| Email |
drnita6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nita Kedar |
| Designation |
HOD and Professor |
| Affiliation |
Government Ayurveda College And Hospital , Nagpur |
| Address |
Department Of Shalyatantra OPD No.3 At Government Ayurveda College and Hospital Sakkardara Square Nagpur MAHARASHTRA 440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9422117613 |
| Fax |
|
| Email |
drnita6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College and Hospital, Nagpur , Maharashtra, India, 440024 |
|
|
Primary Sponsor
|
| Name |
Khedkar Sonali Jagdish |
| Address |
At Government Ayurveda College and Hospital, Nagpur, Maharashtra, India, 440024 |
| 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 Khedkar Sonali Jagdish |
Government Ayurveda College and Hospital |
Department Of Shalyatantra OPD No.3 At Government Ayurveda College and Hospital Sakkardara Square Nagpur MAHARASHTRA 440024
Nagpur
MAHARASHTRA |
9834564082
sonalikhedkar33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Ayurveda College , Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: BAGANDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kShArasUtra, क्षारसूत्र | (Procedure Reference: Chakradatta Arshadhikar, Procedure details: lox 25% jelly applied to external opening
Standard Ksharsutra inserted through exeternal opening which comes out through internal opening
tract length calculated
Ksharsutra change will be done)
| | 2 | Intervention Arm | Procedure | - | bastikarma, बस्तिकर्म | (Procedure Reference: sushrut samhita chikitsastahn 8/47, Procedure details: Lox 2% jelly applied to external opening
5ml Nyagrodh Tail loaded in syringe & inserted through external opening which comes out through internal opening)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing to participate in the study
2.patient having age between 18-70 yrs
3.patients will be selected irrespective of sex, marital status, religion, educational status
4.Patients of Bhagandara having single tract low anal fistula
5.patients with tract length upto 6cm
6..co-operative patients
|
|
| ExclusionCriteria |
| Details |
1.Patient not willing to participate in the study
2.Patients with high anal fistula with tract length more than 6cm
3.Patients suffering from any major illness (Chrons disease, Ulcerative colitis, Multiple Fistula in
ano, carcinoma of Rectum)
4.Immuno-compromised patients
5.Non- cooperative patients
6.Patients having Uncontrolled Dibetes Mellitis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To study the effect of Nyagrodh Tail Pooran in the Bhagandara with special reference to Fistula in ano
2.To study the effect of ksharasutra in the Bhagandara with special refernce to Fistula in ano
3.To compare the effect of Nyagrodh tail Pooran And Ksharsutra in the Bhagandara with special refernce to Fistula in ano |
1st day,7th day,14th day,21th day,28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the effect of Nyagrodh Tail Pooran in unit Healing time
2.To study the literature regarding drug and disease through ayurvdic text and Morden Medicine Science |
1st day,7th day,14th day,21th day,28th day |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
02/05/2025 |
| 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
|
After clearance from the Institutional Ethics Commitee Government Ayurveda College and Hospital, Nagpur Screening of Population will be done from Opd IPd and Casualty of our Institute, 74 patients of Bhagandara ( Fistula In Ano ) will be included.If Patients fulfil the criteria of Inclusion, Subject would also given freedom to ask their questions all the questions would answer. If he/she agree to participation in study and found fit to include the patient will include in the study. Study design : Open Labelled Randomized Controlled Trial
Study Setting :The patients attending OPD and IPD of Shalyatantra Department of our institute will be selected as subject for this research study.
Study Population : Patients attending OPD and IPD of Shalyatantra Department having sign and symptoms of Bhagandara will be selected.
Duration of Study : 18 month after completion of Pre MS
Duration of Treatment : 28days
Sample size
Percentage of effectiveness of Standard Ksharsutra in the management of Bhagandara.....p1=80%
Percentage of effectiveness of Nyagrodh Tail Pooran in the management of Bhagandara.....p1=81%
alpha error =5%
Power(1-Beta ) = 80%
Required sample size = 34 per Group
Therefore considering 10% dropout /Nonresponse, Final sample size in each group =37
MATCHING CRITERIA
1) Patients having age between 18-70 yrs
2) Patients having clinical signs and symptoms of Bhagandara ( Fistula In Ano)
DIAGNOSTIC CRITERIA
Clinical diagnosis will be done by assessing the presenting signs and symptoms. 1) Pain 2) Discharge through external opening 3) Length of tract in cms
METHODS OF MEASUREMENT -
1) Subjective Criteria - Pain (Shoola) Visual Scale Analouge Scale for Pain
2) Objective Criteria - Discharge through external Opening Length of tract in cm Healing Time
CLINICAL INVESTIGATIONS - CBC with ESR BSL Fasting Postpradial Urine Routine , Microscopic HIV MRI Fistulogram (If necessary)
GROUP A - Standard Ksharsutra Insertion for every 7th day till 28 days
GROUP B - Nyagrodh Tail Pooran daily for 28 days
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