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CTRI Number  CTRI/2016/11/007496 [Registered on: 25/11/2016] Trial Registered Retrospectively
Last Modified On: 28/11/2016
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   “A Comparative Clinical Study Of Yashtimadhu Ghrita And Lignocaine-Nifedipine Ointment In The Management Of Parikartika (Acute Fissure- In- Ano).”  
Scientific Title of Study   “A COMPARATIVE CLINICAL STUDY OF YASHTIMADHU GHRITA AND LIGNOCAINE-NIFEDIPINE OINTMENT IN THE MANAGEMENT OF PARIKARTIKA (ACUTE FISSURE- IN- ANO).”  
Trial Acronym  parikartika 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  JIGNA PATEL 
Designation  M.S AYU SHALYA TANTRA 
Affiliation  IPGT AND RA 
Address  ROOM NO. 223, PG LADIES HOSTEL, IPGT AND RA HOSPITAL GUJARAT AYURVEDA UNIVERSITY JAMNAGAR
ROOM NO. 223, PG LADIES HOSTEL, IPGT AND RA HOSPITAL GUJARAT AYURVEDA UNIVERSITY JAMNAGAR
Jamnagar
GUJARAT
361008
India 
Phone  9033307475  
Fax    
Email  dr.jignapatel48@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  DR VDMAHANTA 
Designation  ASSOCIATE PROFESSOR 
Affiliation  IPGT AND RA 
Address  ROOM NO. 631, 6TH FLOOR, IPGT AND RA, GUJARAT AYU UNIVERSITY, JAMNAGAR
ROOM NO. 631, 6TH FLOOR, IPGT AND RA, GUJARAT AYU UNIVERSITY, JAMNAGAR
Jamnagar
GUJARAT
361008
India 
Phone  9408323779  
Fax    
Email  drvyasayu@gmail.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  DR T S DUDHAMAL 
Designation  ASSISTANT PROFESSOR  
Affiliation  IPGT AND RA 
Address  ROOM NO. 628, 6TH FLOOR, IPGT AND RA, GUJARAT AYU UNIVERSITY, JAMNAGAR
ROOM NO. 628, 6TH FLOOR, IPGT AND RA, GUJARAT AYU UNIVERSITY, JAMNAGAR
Jamnagar
GUJARAT
361008
India 
Phone  9428671939  
Fax    
Email  drtsdudhamal@gmail.com  
 
Source of Monetary or Material Support  
IPGT AND RA GUJARAT AYURVED UNIVERSITY, JAMNAGAR 
 
Primary Sponsor  
Name  IPGT AND RA GAU JAMNAGAR 
Address  IPGT AND RA GAU JAMNAGAR, GUJARAT,INDIA 361008 
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 
JIGNA PATEL  IPGT AND RA GAU  IPGT AND RA GAU, JAMNAGAR, GUJARAT 361008
Jamnagar
GUJARAT 		 9033307475

dr.jignapatel48@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  PARIKARTIKA ( ACUTE FISSURE IN ANO),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Local application of Yashthimadhu Ghrita in fissure bed (Parikartika) twice a day after sitz bath for 4 weeks.   Local application of Yashthimadhu Ghrita in fissure bed (Parikartika) twice a day after sitz bath for 4 weeks.  
Comparator Agent  Local application of Lignocaine-nifedipine ointment in fissure bed Parikartika twice a day after sitz bath for 4 weeks  Local application of Lignocaine-nifedipine ointment in fissure bed Parikartika twice a day after sitz bath for 4 weeks 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients of Parikartika (Acute fissure-in-ano) having duration less than 12 weeks.
2.Controlled cases of Diabetese mallitus or Hypertension
 
 
ExclusionCriteria 
Details  1.Fissure-in-ano having duration- more than 12 weeks.
2.Patient below 17 & above 70 years of age.
3.Patient suffering from malignancy.
4.Patient suffering from HIV, VDRL, Hepatitis-B, T.B.
5.Fissure-in-ano associated with piles & fistula.
6.Multiple fissure in ano
7.Uncontrolled cases of Diabetes Mellitus and Hypertension
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
ASSESSMENT WILL BE DONE ON THE BASIS OF SPECIALLY PREPARED PERFORMA FOR ASSESSING RELIEF IN SIGN AND SYMPTOMS BY SCORING PATTERN  ASSESSMENT WILL BE DONE ON THE BASIS OF SPECIALLY PREPARED PERFORMA FOR ASSESSING RELIEF IN SIGN AND SYMPTOMS BY SCORING PATTERN 
 
Secondary Outcome  
Outcome  TimePoints 
1 MONTH  1 MONTH 
 
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 1/ Phase 2 
Date of First Enrollment (India)   20/01/2016 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NOT YET PUBLISHED 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is open label comparative clinical study of local application of yashtimadhu ghrita and lignocaine-nifedipine in the management of parikartika (acute fissure in ano)
Routine blood investigations will be performed to rule out others .
special scoring scale has been prepared based on information in 
ayurvedic  classical texts which will be utilized for assessment and evaluation 

METHOD:

·         Grouping of Patients :

The patients shall be randomly allocated into two groups A & B, having minimum 15 patients in each group.

Group-A:  Local application of Yashthimadhu Ghrita in fissure bed (Parikartika) twice a day after sitz bath for 4 weeks.  

Group-B:  Local application of Lignocaine-nifedipine ointment in fissure bed Parikartika twice a day after sitz bath for 4 weeks.

·         Common Treatment for both groups:

1.  Warm water sitz bath with Panchavalkal Kwath, twice a day.

2.  Erandbhrist Haritaki Churna 5gms HS (at bed time) with luke warm water.

·         Procurement of trial drugs

Yashtimadhu ghrit will be procured from pharmacy of Gujrat Ayurved University, Jamnagar.

Lignocaine-nifedipine ointment (anobliss or any branded ointment) will be procured from local market.

·         Duration of treatment

 Four weeks

·         Follow-up Period: One month

·         Laboratory Investigation:

a.     CBC

b.     RBS,

c.     Blood urea, Sr. Creatinine, Sr. Billirubin.

e.     HIV, VDRL, HBsAg

                 f.     Urine analysis- Routine & Microscopic

g.     Stool examination- Routine & Microscopic

·         Other Investigation:

Chest X-Ray, ECG, USG Abdomen, Colonoscopy if required.

OVERALL ASSESSMENT CRITERIA:

     Patients will be assessed as per following gradation:

   1. Complete remission: 100 % improvement in subjective and objective parameter

 2. Marked improvement: 76 – 99 % relief in subjective and objective parameter

 3. Moderate improvement: 51 - 75 % relief in subjective and objective parameter

 4. Mild improvement: 26 - 50 % relief in subjective and objective parameter

 5. Unchanged: Less than 25 % relief in subjective and objective parameter

 
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