| CTRI Number |
CTRI/2020/01/022856 [Registered on: 20/01/2020] Trial Registered Prospectively |
| Last Modified On: |
21/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to reveal better drug of choice between Yashtimadhu Ghrita and Yashtimadhu Ghrita for treatment of Anal-Fisure |
|
Scientific Title of Study
|
COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF YASHTIMADHU GHRITA PICHU AND SHATADHAUTA GHRITA PUCHU IN THE MANAGEMENT OF PARIKARTIKA WITH SPECIFIC REFERENCE TO 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 Manoj Patil |
| Designation |
MS Shalya Tantra |
| Affiliation |
Hon Shri Annasaheb Dange Ayurvedic Medical College |
| Address |
Hon Shri Annasaheb Dange Ayurvedic Medical College
Department Of Shalyatantra
Ashta
Taluka Walva
District Sngli
Sangli
MAHARASHTRA
416301
India |
| Phone |
|
| Fax |
|
| Email |
drpatilmanoj77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Patil |
| Designation |
MS Shalya Tantra |
| Affiliation |
Hon Shri Annasaheb Dange Ayurvedic Medical College |
| Address |
Hon Shri Annasaheb Dange Ayurvedic Medical College
Department Of Shalyatantra
Ashta
Taluka Walva
District Sngli
Sangli
MAHARASHTRA
416301
India |
| Phone |
|
| Fax |
|
| Email |
drpatilmanoj77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj Patil |
| Designation |
MS Shalya Tantra |
| Affiliation |
Hon Shri Annasaheb Dange Ayurvedic Medical College |
| Address |
Hon Shri Annasaheb Dange Ayurvedic Medical College
Department Of Shalyatantra
Ashta
Taluka Walva
District Sngli
Sangli
MAHARASHTRA
416301
India |
| Phone |
|
| Fax |
|
| Email |
drpatilmanoj77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Bhardwaj Bhosekar
57 b Akshat Bangalows
Isbavi
Pandharpur |
|
|
Primary Sponsor
|
| Name |
Dr Bhardwaj Bhosekar |
| Address |
Hon Shri Annasaheb Dange Ayurvedic Medical College |
| 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 Bhardwaj |
Hon Annasaheb Dange Ayurvedic Medical College |
Shalyatantra OPD
Ashta
Dist Sangli
Sangli
MAHARASHTRA |
8983088287
bhardwajbhosekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy patients only having fissures |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Shatadhauta Ghrita |
1 ml of drug will be kept in anal canal soaked in pichu twice a day
that is in Morning after bath
and at bedtime |
| Intervention |
Yashtimadhu Ghrita |
1 ml of drug will be kept in anal canal soaked in pichu twice a day
that is in Morning after bath
and at bedtime |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient suffering from only fissure-in-ano
having typical features like Ulcer in anal region, constipation,excruting pain after and during defecation in anal region, bleeding per rectum, burning sensation, presence of sphincter spasm will be selected |
|
| ExclusionCriteria |
| Details |
with any other ano rectal disease
suffering from std like HIV, HBsAg, HCV
below age 18 and above age 60
carcinoma or malignancy suspected, Diabetis Mellitus, Multiple fisure-in-ano |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms like itching, pain, bleeding, and Reduced in size/number in fissure, or completely healing |
Will examine patient on 7 , day 14 and day 21 and compare with day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced constipation hence reduce chanced of recurance |
Will examine patient on day 7 , day 14 and day 21 |
|
|
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)
|
20/01/2020 |
| 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)
Modification(s)
|
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
|
Drug will used in pichu form means cotton soaked with drugand will kept in anal region for 14 days will kept twice daily in morning after bath and at bed time examination will done on 7 th day , 14 th day and 21 th day these findings will compare with 1 st visit symptoms |