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CTRI Number  CTRI/2014/08/004807 [Registered on: 01/08/2014] Trial Registered Retrospectively
Last Modified On: 31/07/2014
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Management of fistula-in-ano with Ksharasootra (medicated thread) 
Scientific Title of Study   Efficacy of Guggulu Based Kshara sootra in Bhagandara with partial Fistulectomy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dudhamal Tukaram Sambhaji 
Designation  Assistant Professor 
Affiliation  IPGTRA 
Address  Dept of Shalya Tantra Institute for post Grsduate Teaching and research in Ayurveda Gujarat Ayurved University Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9428671939  
Fax  02882676856  
Email  drtsdudhamal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rakesh Kumar Meena 
Designation  M S halya tantrascholar 
Affiliation  IPGTRA 
Address  Dept of Shalya Tantra Institute for post Grsduate Teaching and research in Ayurveda Gujarat Ayurved University Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9687442878  
Fax  02882676856  
Email  drrakeshipgt@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dudhamal Tukaram Sambhaji 
Designation  Assistant Professor 
Affiliation  IPGTRA 
Address  Dept of Shalya Tantra Institute for post Grsduate Teaching and research in Ayurveda Gujarat Ayurved University Jamnagar


GUJARAT
361008
India 
Phone  9428671939  
Fax  02882676856  
Email  drtsdudhamal@gmail.com  
 
Source of Monetary or Material Support  
IPGTRA GAU Jamnagar 
 
Primary Sponsor  
Name  IPGTRA Jamnagar 
Address  IPGTRA Gujarat Ayurved University Jamnagar 
Type of Sponsor  Research institution and hospital 
 
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 T S Dudhamal  IPGTRA Jamnagar  Dept of Shalya Tantra IPGTRA Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT 		 9428671939
02882676856
drtsdudhamal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC IPGTRA Jamnagar  Not Applicable 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Boil at perianl region intermittent pain and discharge per anal ocassional itching history of perianal abscess,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Application of Guggulu based Ksharasutra followed by partial Fistulectomy  First partial fistulectomy will be done and later on application of Guggulu based Ksharasutra in fistulous tract will be done once under anesthesia. The new Ksharasutra will be replaced by railroad technique by weekly interval till cut through and healing of fistulous tract. 
Intervention  Application of Guggulu based Ksharasutra in fistula in ano.   Application of Guggulu based Ksharasutra in fistulous tract once under anesthesia. The new Ksharasutra will be replaced by railroad technique by weekly interval till cut through and healing of fistulous tract.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Vataja Bhagandara (Shataponaka) Pitaja Bhagandara (Ushtagreeva) Kaphaja Bhagandara (Parisravi) Vata-Pittaja Bhagandara (Parikshepee) Vata-Kaphaja Bhagandara (Riju) and Arsho Bhagandara {(Kapha Pittaja) (Piles fistula)}
Bhagandara of above type with Parikartika (Fistula in ano with fissure in ano)
Fistula-in-ano with controlled diabetes mellitus
Fistula in ano with controlled Tuberculosis
 
 
ExclusionCriteria 
Details  Sannipataja Bhagandara (Shambookavarta) and Agantuja Bhagandara (Unmargi)
Fistula in ano associated with one or more of the following conditions
Uncontrolled Tuberculosis
Uncontrolled Hypertension
Uncontrolled Diabetes mellitus
Osteomyelitis,
Chronic or acute ulcerative colitis
Crohn’s disease
Ano-rectal & other Malignancy
Venereal diseases, HIV and HBsAg Positive
Pregnancy
Fistula other than ano rectal
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief from sign and symptoms of fistula in ano
minimum scar at operate site
less recurrence rate  		 After cut through of total tract, depends on length of fistula tract. It may between 1 months to 3 months.
minimum scar at operate site
less recurrence rate  
 
Secondary Outcome  
Outcome  TimePoints 
Relief from sign and symptoms of fistula in ano
minimum scar at operate site
less recurrence rate  		 It depends upon the leghth of tract may be 1 month to 3 months. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   13/09/2013 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The patients of fistula in ano will be selected and divided in to two groups. In group A Guggulu based Khsarasutra will be applied and observed the patients upto complete cutting of ksharasutra and healing of tract. In group B partial fistulectomy along with application of Guggulu based Khsarasutra will be done. The patients will be observed upto complete cutting of ksharasutra and healing of tract. The observed findings will be recorded in the research proforma. The observed data will be statistically analized for final results. The outcome of findings will be vividely discussed and final conclusion will be drawn after completion of the study. 
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