| CTRI Number |
CTRI/2025/02/080032 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
02/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Prapoundrikadi Ghrita in Anal Fissure |
|
Scientific Title of Study
|
A clinical study to evaluate the effect of Prapoundrikadi Ghrita in Parikartika (Fissure-in-ano) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amitabh Singh |
| Designation |
Pg Scholar |
| Affiliation |
Quadra Institute of Ayurveda and Hospital |
| Address |
Opd No 1 Department of Shalya Tantra Quadra Institute of Ayurveda and Hospital NH58 Roorkee Haridwar Road Near Montfort School Roorkee 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
8563971571 |
| Fax |
|
| Email |
doctorq985@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhoomi Soni |
| Designation |
Associate Professor |
| Affiliation |
Quadra Institute of Ayurveda and Hospital |
| Address |
Opd No 1 Department of Shalya Tantra Quadra Institute of Ayurveda and Hospital NH58 Roorkee Haridwar Road Near Montfort School Roorkee 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
9008637659 |
| Fax |
|
| Email |
quadrashalya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amitabh Singh |
| Designation |
Pg Scholar |
| Affiliation |
Quadra Institute of Ayurveda and Hospital |
| Address |
Opd No 1 Department of Shalya Tantra Quadra Institute of Ayurveda and Hospital NH58 Roorkee Haridwar Road Near Montfort School Roorkee 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
8563971571 |
| Fax |
|
| Email |
doctorq985@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd No 1 Department of Shalya Tantra Quadra Institute of Ayurveda and Hospital NH58 Roorkee Haridwar Road Near Montfort School Roorkee 247667 |
|
|
Primary Sponsor
|
| Name |
Amitabh Singh |
| Address |
Opd No 1 Department of Shalya Tantra Quadra Institute of Ayurveda and Hospital NH58 Roorkee Haridwar Road Near Montfort School Roorkee 247667 |
| 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 Amitabh Singh |
Quadra Institute of Ayurveda and Hospital |
Opd No 1 Department of Shalya Tantra Quadra Institute of Ayurveda and Hospital NH58 Roorkee Haridwar Road Near Montfort School Roorkee 247667
Hardwar
UTTARANCHAL |
8563971571
doctorq985@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Quadra Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K602||Anal fissure, unspecified. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Prapoundrikadi Ghrita, Reference: Sushrut Samhita Chikitsa Sthana Adhyay 16 Shlok 14, Route: Rectal, Dosage Form: Ghrita, Dose: 50(ml), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients age ranging from 18 to 60 years.
2. Patients clinically diagnosed by PR examination as having Parikartika.
3. Controlled case of Hypertention and Diabetes mellitus. |
|
| ExclusionCriteria |
| Details |
1. HIV, HCV, HBsAg positive patients.
2. Patients having Parikartika secondary to Ulcerative colitis, Syphilis, Tuberculosis, Crohns disease.
3. Patients having anal or peri anal Cancer.
4. Fissure-in-ano associated with Piles, Fistula-in-ano.
5. Uncontrolled Diabetes mellitus and uncontrolled Hypertention.
6. Other systemic serious illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment based on subjective parameters-
1.Bleeding
2.Pain
3.Constipation |
First follow up- on 7th day
Second follow up- 7 days after first follow up
Third follow up- 14 days after second follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment based on objective parameters-
1.Size of split
2.Skin tag |
Assessment will be done on 0 day & 28 day and inbetween |
|
|
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)
|
13/02/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is open label clinical study to evaluate the effect of Prapoundrikadi Ghrita in Parkartika. Patients will be selected randomly irrespective of gender race religion occupation. Total 30 patients will be registered for this study from OPD and IPD of Shalya Tantra department of Quadra Institute of Ayurveda Roorkee. The patients between age group 18 to 60 years. The assessment of the trial will be done on subjective and objective parameters. Deatailed profarma will be prepared on the basis of Ayurvedic and allied sciences. Observation of patients will be done before during and after completion of trial. Data depending upon above subjective and objective paramerters and other variables will be collected and analyzed statistically. |