| CTRI Number |
CTRI/2023/08/057011 [Registered on: 28/08/2023] Trial Registered Prospectively |
| Last Modified On: |
16/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Durvadhya Ghrita local application in Parikartika |
|
Scientific Title of Study
|
Randomised open controlled clinical study to evaluate the effect of Durvadhya Ghrita local application in Parikartika with special reference to 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 |
Dr Mangesh Chokinath Mendhe |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College PGT & RC Kodoli |
| Address |
Yashwant Ayurvedic College PGT & RC Kodoli, Department of Shalya tantra OPD no 4
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9890457202 |
| Fax |
|
| Email |
drmangeshmendhe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sayaji Desai |
| Designation |
Associate professor |
| Affiliation |
Yashwant Ayurvedic College PGT & RC Kodoli |
| Address |
Yashwant Ayurvedic College PGT & RC Kodoli
Department of Shalya tantra
OPD no 4
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423282354 |
| Fax |
|
| Email |
drsayaji@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mangesh Chokinath Mendhe |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College PGT & RC Kodoli |
| Address |
Yashwant Ayurvedic College PGT & RC Kodoli
Department of Shalya tantra
OPD no 4
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9890457202 |
| Fax |
|
| Email |
drmangeshmendhe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College PGT & RC, Kodoli |
|
|
Primary Sponsor
|
| Name |
Dr. Mangesh Chokinath Mendhe |
| Address |
Yashwant Ayurvedic College PGT & RC, Kodoli
Kolhapur |
| 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 Mangesh Chokinath Mendhe |
Yashwant Ayurvedic College PGT and RC Kodoli dist Kolhapur |
OPD no. 4
Department of Shalya tantra
Yashwant Ayurvedic College PGT and RC
Kodoli
Kolhapur
MAHARASHTRA |
9890457202
drmangeshmendhe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatyadi Ghrita , Reference: Sharangdhar Samhita madhyam khanda 10/56-57, Route: Topical, Dosage Form: Ghrita, Dose: 200(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Durvadhya Ghrita , Reference: Chakrdatta 47/79-80, Route: Topical, Dosage Form: Ghrita, Dose: 200(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age group 18 to 70 yrs of either gender
2. Patients of irrespective of age, sex, socio economic status & prakriti.
3. Complaining of pain with or without bleeding per rectum during and/or after defecation with or without other symptoms like itching, discharge, constipation, with / or without pain not more than one year.
4. Anal fissure examined and confirmed by anal examination
5. Patients willing to give written informed consent.
6. ANC patient without any complication
|
|
| ExclusionCriteria |
| Details |
1. Patient suffering from malignancy of any organ or ano rectucal were excluded.
2. Patient suffering from chronic anaemia, immune compromised HIV, VDRL, Hepatitis-B, T.B were excluded.
3. Acute fissure-in-ano associated with piles & fistula.
4. Patients having multiple fissure in ano will be excluded.
5. Uncontrolled cases of Diabetes Mellitus and Hypetension |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Durvadhya Ghrita local application in Parikartika w.s.r. to fissure in ano. |
1) Before treatment
2) 5th day
3) 10th day
4) 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To study the scattered literature in various text about parikartika 2 To study pathophysiology of Parikartika w.s.r, to fissure in ano according to Ayurveda & modern science resp. 4 To study the drug Durvadhya Ghrita according to ayurvedic of view |
15 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2023 |
| 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="6"
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
|
Randomised open controlled clinical study of Durvadhya Ghrita local application in Parikartika with special reference to fissure in ano. The study will be carried out in OPD no 4 of shalyatantra department of Yashwant Ayurvedic College, Kodoli, Kolhapur. The observation would be drawn on the basis of symptoms after treatment given. |