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CTRI Number  CTRI/2023/03/050372 [Registered on: 06/03/2023] Trial Registered Prospectively
Last Modified On: 23/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Basti]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study of efficacy of Yashtimadhu Krushntil Kalka Siddha Tail Matrabasti in the treatment of Parikartika (Acute Fissure in ano) 
Scientific Title of Study   Randomized controlled clinical trial to study efficacy of Yashtimadhu Krushntil Kalka Siddha Tail Matrabasti in the treatment of Parikartika (Acute Fissure 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 Jyoti Balaso Godase 
Designation  PG Scholar 
Affiliation  Government Ayurved College and Hospital, Vazirabad, Nanded 
Address  Dept of Shalyatantra, Government Ayurved College, Vazirabad, Nanded

Nanded
MAHARASHTRA
431601
India 
Phone  9765205826  
Fax    
Email  jyotigodase4567@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajendra Sonekar 
Designation  H. O. D. and Professor  
Affiliation  Government Ayurved College and Hospital, Vazirabad, Nanded 
Address  Dept of Shalyatantra, Government Ayurved College, Vazirabad, Nanded

Nanded
MAHARASHTRA
431601
India 
Phone  9822578033  
Fax    
Email  rajendra.sonekar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajendra Sonekar 
Designation  H. O. D. and Professor  
Affiliation  Government Ayurved College and Hospital, Vazirabad, Nanded 
Address  Dept of Shalyatantra, Government Ayurved College, Vazirabad, Nanded


MAHARASHTRA
431601
India 
Phone  9822578033  
Fax    
Email  rajendra.sonekar@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurved College, Vazirabad, Nanded 
 
Primary Sponsor  
Name  Dr. Jyoti Balaso Godase 
Address  Dept of Shalyatantra, Government Ayurved College and Hospital, Vazirabad, Nanded 
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 Jyoti Balaso Godase  Government Ayurved Hospital, Nanded  Dept of Shalyatantra Hospital building OPD NO. 6 & 7 and IPD ward No. 51 & 63
Nanded
MAHARASHTRA 		 9765205826

jyotigodase4567@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K600||Acute anal fissure. Ayurveda Condition: PARIKARTIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Lidocaine(1.5%)and Nifedipine(0.3%) creamLocal application twice a day after defecation and at bedtime
2Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Charak Samhita, Procedure details: Yashtimadhu Krushntil Kalk Siddha tail Matrabasti 60ml once a day for 7 days.)
(1) Medicine Name: Yashtimadhu Krushntil Kalk Siddha tail, Reference: Charak samhita, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients clinically diagnosed / confirmed by Inspections as having Parikartika (fissure in-ano)
2) Patient age group between 18-60 years.
3) Patients willing to give consent and able to participate in the study for 28 days.
4) Patients irrespective of gender, religion, their caste, marital status and economic
class will be included. 
 
ExclusionCriteria 
Details  1. Patients who are contraindicated for basti (basti-anarha).
2. Patients having Parikartika (Fissure in-Ano) secondary to any other disease will be
excluded.
3. Patients with uncontrolled systemic disease as like diabetes and Hypertension will be
excluded.
4. Patients with infectious diseases like HIV and Hepatitis and syphilis will be excluded.
5. Patients with other co-existing anal pathologies like haemorrhoid, fistula in-ano,
prolapsed rectum, rectal polyp, Ca rectum, will be excluded.
6. Patients having any other sever systemic disorders will be excluded. 
 
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 
Complete healing of fissure   22 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Complete healing of fissure 2.Decreased pain during defecation
3. Decreased PR bleeding
4. Decreased constipation
5. Decreased anal spasm 		 22 days 
 
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   Phase 2 
Date of First Enrollment (India)   20/03/2023 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is prospective, randomized, open labelled, controlled clinical study of use of Yashtimadhu Krushntil Kalk Siddha Tail Matrabasti in the dose of 60ml per day  for 7 days along with sits bath- lukewarm water twice a day after defecation with laxative- Gandharva Haritaki 3gm orally at bed time for 21 days with assessment and follow up on 0th, 8th, 14th and 22nd day in the treatment of Parikartika ( Acute Fissure in ano). This study is conducted as PG course at single center. The primary outcome is to study efficacy of Yashtimadhu Krushntil Kalk Siddha tail Matrabasti in the treatment of Parikartika (Acute Fissure in ano) 
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