| CTRI Number |
CTRI/2022/08/045017 [Registered on: 29/08/2022] Trial Registered Prospectively |
| Last Modified On: |
28/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Gunvati Varti in the management of parikartika w.s.r to Chronic Fissure In Ano |
|
Scientific Title of Study
|
A Clinical study of Gunvati varti in the management of Parikartika w.s.r to chronic 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 Kavita Gurjar |
| Designation |
M.S. Scholar |
| Affiliation |
Madan Mohan Malviya Govt. Ayurved College Udaipur |
| Address |
PG Department Of Shalya Tantra Madan Mohan Malviya Govt. Ayurved
College Udaipur Rajasthan
Udaipur
RAJASTHAN
India
PG Department Of Shalya Tantra Madan Mohan Malviya Govt. Ayurved
College Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
6377325658 |
| Fax |
|
| Email |
kavitagurjar920@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Harimohan Meena |
| Designation |
Professor |
| Affiliation |
Madan Mohan Malviya Govt. Ayurved College Udaipur |
| Address |
PG Department Of Shalya Tantra Madan Mohan Malviya Govt. Ayurved
College Udaipur Rajasthan
Udaipur
RAJASTHAN
PG Department Of Shalya Tantra Madan Mohan Malviya Govt. Ayurved
College Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9782166260 |
| Fax |
|
| Email |
dr_harimohan@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Harimohan Meena |
| Designation |
Professor |
| Affiliation |
Madan Mohan Malviya Govt. Ayurved College Udaipur |
| Address |
PG Department Of Shalya Tantra Madan Mohan Malviya Govt. Ayurved
College Udaipur Rajasthan
Udaipur
RAJASTHAN
PG Department of Shalya Tantra Madan Mohan Malviya Govt. Ayurved
College Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9782166260 |
| Fax |
|
| Email |
dr_harimohan@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Government Ayurveda college Udaipur |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurveda college Udaipur |
| Address |
Madan Mohan Malviya Government Ayurveda college Udaipur
313001
|
| Type of Sponsor |
Government medical college |
|
|
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 Harimohan Meena |
Madan Mohan Malviya Government Ayurveda college Udaipur |
Opd room No. 1, PG
dept. Of Shalya Tantra,
College Hospital Madan
Mohan Malviya
Government Ayurveda
college Udaipur.
Udaipur
Rajasthan
Udaipur
RAJASTHAN |
9782166260
dr_harimohan@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Madan Mohan Malviya Government Ayurved College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K601||Chronic anal fissure. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: GUNVATI VARTI, Reference: Bhesajya Ratnavali 50/7,8 , Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 3(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: . JATAYADI TAIL, Reference: Sharanghadar Samhita 9/168,178 , Route: Rectal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Chronic fissure
2. Fissure due to primary condition
3. Patients are having sign and symptoms of Parikartika will be included.
5. Those ready to give written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Acute fissure
2. Fissure due to secondary condition
3. Rectal polyp
4. CA of Anus &Rectum
5. Uncontrolled Diabetes mellitus
6. HIV and immune deficiency syndrome.
7. Immunosuppressive medications.
8. Internal piles
9. External thrombosed piles |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in sign and symptoms of parikartika w.s.r. Chronic fissure in ano are includs
1. Pain in anal region
2. Bleeding per anum
3. Odour
4.Constipation
5. Tenderness in anal region |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in sign and symptoms of parikartika w.s.r. Chronic fissure in ano are includs
1. Pain in anal region
2. Bleeding per anum
3. Odour
4. Constipation
5. Tenderness in anal region |
1 week,2 week, 3week |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2022 |
| 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="0"
Months="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A clinical study of Gunvati Varti in the management of Parikartika w.s.r. to Chronic Fissure in Ano. It is a Randomised, Parellel Group. In this group A (15 Patients) is administered with Gunvati Varti and group B (15 Patients) is administered with Jatyadi Taila. |