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CTRI Number  CTRI/2020/10/028304 [Registered on: 08/10/2020] Trial Registered Prospectively
Last Modified On: 07/10/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the effect of Syandan Tail in the healing effect of Bhagandar after instillation in operated site(Fistula in Ano) 
Scientific Title of Study   Randomized Open Control Clinical Study to evaluate the healing effect of Syandan Tail in the management of Bhagandar with special reference to 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 Vivek Choubey 
Designation  PG Scholar  
Affiliation  Yashwant Ayurvedic College, Post Graduate Training & Research Centre, Kodoli  
Address  Post Graduate Shalya Department,Second Floor Room No.4,Yashwant Ayurvedic Medical College Kodoli Tal : Panhala, Dist : Kolhapur
Yashwant Ayurvedic College, Post Graduate Training & Research Centre, Kodoli,Tal : Panhala, Dist : Kolhapur
Kolhapur
MAHARASHTRA
416114
India 
Phone  7000257463  
Fax  02328-222089  
Email  nagarjunvashisht@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Srinivas Turlapati 
Designation  HOD & Professor Shalya Department 
Affiliation  Yashwant Ayurvedic Medical College 
Address  Post Graduate Shalya Department,Second Floor Room No.4,Yashwant Ayurvedic Medical College Kodoli Tal : Panhala, Dist : Kolhapur
Yashwant Ayurvedic Medical College Kodoli Tal : Panhala, Dist : Kolhapur
Kolhapur
MAHARASHTRA
416114
India 
Phone  9503147698  
Fax  02328-222089  
Email  drsrinivast@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Srinivas Turlapati 
Designation  HOD & Professor Shalya Department 
Affiliation  Yashwant Ayurvedic Medical College 
Address  Post Graduate Shalya Department,Second Floor Room No.4,Yashwant Ayurvedic Medical College Kodoli Tal : Panhala, Dist : Kolhapur
Yashwant Ayurvedic Medical College Kodoli Tal : Panhala, Dist : Kolhapur
Kolhapur
MAHARASHTRA
416114
India 
Phone  9503147698  
Fax  02328-222089  
Email  drsrinivast@gmail.com  
 
Source of Monetary or Material Support  
Yashwant Ayurvedic College, Post Graduate Training & Research Centre and Hospital Kodoli,kolhapur,Maharashtra 
 
Primary Sponsor  
Name  Dr Vivek Choubey 
Address  Yashwant Ayurvedic Medical College Kodoli Tal : Panhala, Dist : Kolhapur – 416114 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vivek Choubey  Yashwant Ayurvedic College, Post Graduate Training & Research Centre and Hospital Kodoli  Shalya Tantra Department OPD Room no.4 and Shalya Tantra IPD Ward.
Kolhapur
MAHARASHTRA 		 7000257463

nagarjunvashisht@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe Yashwant Ayurvedic Medical College P.G.T.& R.C.,Kodoli,Kolhapur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K605||Anorectal fistula,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Sucarlfate,Metronidazole with Lignocaine Hydrochloride Cream ,Triphala Guggul 500mg   Sucarlfate,Metronidazole with Lignocaine Hydrochloride Cream Dose in ml as per size of Fistula Tract once in a day Syringing or instillation done externally in the Fistula Tract day afer Ksharsutra apllication or partial Fistulectomy with Ksharsutra application daily till 30 days daily,Internally Triphala Guggul 500mg TID for 30 days of patient having inclusion Criteria. 
Intervention  Syandan Tail,Triphala Guggul 500mg   Syandan Tail Dose in ml as per size of Fistula Tract once in a day Syringing or instillation done externally in the Fistula Tract day afer Ksharsutra apllication or partial Fistulectomy with Ksharsutra application daily till 30 days daily,Internally Triphala Guggul 500mg TID for 30 days of patient having inclusion Criteria. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient having sign & symptom of bhagandar with special reference to fistula in ano.
All types of Fistula in ano will be taken.
Patient Undergoing ksharsutra treatment or done partial Fistulectomy with ksharsutra taken. 
 
ExclusionCriteria 
Details  known Cases of Hiv,Hepatitis B,Tuberculosis,Infections,any systemic disease.
Known cases of Fistula associaed with Fissure In ano,haemorrhoids,pregnancy,Malignacy.
Fistula Connected with other organs like urethra,vagina etc 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pain,Discharge,Granulation of the fistula tract,Local tenderness,Healing time  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Pain,Discharge,Granulation of the fistula tract,Local tenderness,Healing time  at every 7th day or last day of every week till 30 days. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 1/ Phase 2 
Date of First Enrollment (India)   10/10/2020 
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="1"
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)?  

Response - NO
Brief Summary  
 This Study is RANDOMIZED OPEN CONTROLLED CLINICAL STUDY TO EVALUATE HEALING EFFECT OF SYANDAN TAIL IN THE MANAGEMENT OF BHAGANDAR WITH SPECIAL REFERENCE TO FISTULA IN ANO.

Intervention:

Group

Trial Group

Control Group

Drug

Syandan Tail

Sucralfate,metronidazole                                                                                                                             with Lignocaine Hydrochloride

Cream

Form

Tail

Cream

Dose

Nadi Pooran (Instillation) as per size of tract

Nadi Pooran (Instillation) as per

size of tract

Time of administration

2nd to 7th day of every week upto 30days/daily

2nd to 7th day of every

Week upto 30 days/daily

Duration

30 days

30 days

Internally

Triphala Guggul 500mg TID for 30 days.

Triphala Guggul 500mg TID for

30 days.

Diet

Pathyakar Ahar Vihar

Pathyakar Ahar vihar




Follow up and assessments:

     Infiltration will be done on a daily basis. But assessment will be done by 7 days intervals;

     viz., on 0,7th14th and 21st and 30th day..


 
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