| CTRI Number |
CTRI/2025/07/090754 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Check the Painkiller effect of Gangeruki Ointment In Pain Of Fissure. |
|
Scientific Title of Study
|
To Evaluate The Efficacy Of Gangeruki(Grewia Tenax) Malhar In Pain Management In Gud 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 |
Gaurav Kumar Sharma |
| Designation |
MS SCHOLAR |
| Affiliation |
Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
PG Department Of Shalya Tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8441970133 |
| Fax |
|
| Email |
gauravsharma04772@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Prof(Dr) Rajesh Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
PG Department Of Shalya Tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636520573 |
| Fax |
|
| Email |
guptadrrajeshkumargupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjay srivastava |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
PG Department Of Shalya Tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037
RAJASTHAN
342037
India |
| Phone |
09414410383 |
| Fax |
|
| Email |
sanjayphyayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Jodhpur India 342304 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Jodhpur 342304 |
| 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 |
| Dr Gaurav Kumar Sharma |
Room No 14 Shalya Department Sanjeevani Chikitsalaya Karwar Jodhpur |
Dr sarvepalli radhakrishnan rajasthan ayurveda university karwar jodhpur 342304
Jodhpur
RAJASTHAN |
08441970133
gauravsharma04772@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Post Graduate Institute Of Ayurved Jodhpur |
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: Gangeruki Malahara, Reference: Sharangdhar Madhyam Khand 1 , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients with classical signs and symptoms of GudaParikartika. |
|
| ExclusionCriteria |
| Details |
1. Patient suffering from AIDS and Hepatitis B
2. Patients related with any malignancy of Anorectal Region
3. Patient suffering from uncontrolled diabetes and tuberculosis
4. Patient suffering from VDRL |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish efficacy of Gangeruki Malhar to relieve pain in fissure in Ano |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To know anaesthetic effect of gangeruki malhar
2 To evaluate adverse drug reaction |
6 weeks |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2025 |
| 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="0"
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
|
Application of Gangeruki Malhar in the patients suffering from Fissure in Ano to know its effect in the pain management in fissure. |