| CTRI Number |
CTRI/2023/06/054408 [Registered on: 26/06/2023] Trial Registered Prospectively |
| Last Modified On: |
23/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficasy of Yastimadhu Ghrita And Triphala Guggulu in Acute Anal Fissure (Parikartika) |
|
Scientific Title of Study
|
Clinical study on Parikartika and its management with Yastimadhu Ghrita and Triphala Guggulu w s r 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 Buddhadeba Mishra |
| Designation |
Associate Professor |
| Affiliation |
Govt Ayurvedic College and Hospital |
| Address |
Department of Shalya Tantra
Govt Ayurvedic College and Hospital
Balangir
Balangir
ORISSA
767001
India |
| Phone |
9861328449 |
| Fax |
|
| Email |
drbuddhadebamishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Arun Kumar Das |
| Designation |
Principal cum Superintendent |
| Affiliation |
Govt Ayurvedic College and Hospital |
| Address |
Office of Principal
Department Of Rasashastra
Govt Ayurvedic College and Hospital
Balangir
Balangir
ORISSA
767001
India |
| Phone |
9861229623 |
| Fax |
|
| Email |
dasarun1969@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Arun Kumar Das |
| Designation |
Principal cum Superintendent |
| Affiliation |
Govt Ayurvedic College and Hospital |
| Address |
Office of Principal
Department of Rasashastra
Govt Ayurvedic College and Hospital
Balangir
Balangir
ORISSA
767001
India |
| Phone |
9861229623 |
| Fax |
|
| Email |
dasarun1969@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Ayurvedic College and Hospital
Balangir
Odisha |
|
|
Primary Sponsor
|
| Name |
Dr Buddhadeba Mishra |
| Address |
Associate Professor
Dept of Shalya Tantra
Govt Ayurvedic College and Hospital
Balangir
Odisha 767001 |
| 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 |
| Prof Dr Arun Kumar Das |
Govt Ayurvedic College and Hopsital |
OPD and IPD
Department of Shalya Tantra
Balangir Odisha
Balangir
ORISSA |
9861229623
dasarun1969@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
|
|
|
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: Triphala Guggulu, Reference: Sharangdhar Samhita, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Ushna Jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yastimadhu Ghrita, Reference: Sushruta Samhita, Route: Topical, Dosage Form: Ghrita, Dose: 0(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphala Guggulu, Reference: Sharangdhar Samhita, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Ushna Jala), Additional Information: -(2) Medicine Name: Yastimadhu Ghrita, Reference: Sushruta Samhita, Route: Topical, Dosage Form: Ghrita, Dose: 0(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient diagnosed with clinical signs and symptoms of acute fissure in ano (less than 6 weeks) like pain in anal verge, bleeding per anus, constipation, Itching.
|
|
| ExclusionCriteria |
| Details |
1. Diagnosed case of Chronic anal fissure.
2. Age group below 18 years and above 60 years
3. Associated with comorbidities like diabetes mellitus , tuberculosis, STD, Fistula in Ano, Haemorrhoids, Perianal abscess, Prolapsed rectum, Anal stenosis, Carcinoma rectum. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To heal the linear ulcer at anal verge. |
4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To decrease pain at anal verge
To reduce bleeding per anus |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
03/07/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
CLINICAL STUDY ON PARIKARTIKA AND ITS MANAGEMENT WITH YASTIMADHU GHRITA & TRIPHALA GUGGULU W.S.R TO FISSURE-IN-ANO |