| CTRI Number |
CTRI/2025/02/081241 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of Gairikadya Malahara and Shatadhauta Ghrita lepa in the management of Parikartika with Special Referance to Acute Fissure in Ano |
|
Scientific Title of Study
|
A comparative clinical study of gairikadya malahara and shatadhauta ghrita lepa in the management of parikartika with special referance to acute 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 Praveenakumar Annasab Magadum |
| Designation |
Postgraduate resident |
| Affiliation |
Dr N A Magadum Ayurvedic Medical College,Hospital and Research Centre |
| Address |
Dr N A Magadum Ayurvedic Medical College,Hospital and Research Centre, Department of Shalyatantra Room No 4 Ankali Tq-Chikodi Dist-Belagavi
Dr N A Magadum Ayurvedic Medical College,Hospital and Research Centre, Department of Shalyatantra Room No 4 Ankali Tq-Chikodi Dist-Belagavi
Belgaum
KARNATAKA
591213
India |
| Phone |
9739868446 |
| Fax |
|
| Email |
praveenkumarm1008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr shaikh shaista shabir |
| Designation |
Associate professor |
| Affiliation |
Dr N A Magadum Ayurvedic Medical College,Hospital and Research Centre |
| Address |
Dr N A Magadum Ayurvedic Medical College,Hospital and Research Centre, Department of Shalyatantra Room No 4,Ankali Tq-Chikodi Dist-Belagavi
Dr N A Magadum Ayurvedic Medical College,Hospital and Research Centre, Department of Shalyatantra Room No 4,Ankali Tq-Chikodi Dist-Belagavi
Belgaum
KARNATAKA
591213
India |
| Phone |
8369311754 |
| Fax |
|
| Email |
rajshaista786@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveenakumar Annasab Magadum |
| Designation |
Postgraduate resident |
| Affiliation |
Dr N A Magadum Ayurvedic Medical College,Hospital and Research Centre |
| Address |
Dr N A Magadum Ayurvedic Medical College,Hospital and Research Centre, Department of Shalyatantra Room No 4,Ankali Tq-Chikodi Dist-Belagavi
Dr N A Magadum Ayurvedic Medical College,Hospital and Research Centre, Department of Shalyatantra Room No 4,Ankali Tq-Chikodi Dist-Belagavi
Belgaum
KARNATAKA
591213
India |
| Phone |
9739868446 |
| Fax |
|
| Email |
praveenkumarm1008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr N A Magadum Ayurvedic Medical College,Hospital and Research Centre,Ankali T/Q Chikodi Dist Belagavi Karnataka India 591213 |
|
|
Primary Sponsor
|
| Name |
Dr Praveenakumar Annasab Magadum |
| Address |
Dr N A Magadum Ayurvedic Medical College,Hospital and Research Centre,Ankali Tq-Chikodi Dist-Belagavi Karnataka Pin Code 591213 |
| Type of Sponsor |
Private 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 Praveenakumar Annasab Magadum |
Dr N A Magadum Ayurvedic Medical College,Hospital and Research Centre |
Dr N A Magadum Ayurvedic Medical College,Hospital and Research Centre, Department of Shalyatantra Room No 4,Ankali Tq-Chikodi Dist-Belagavi
591213
Belgaum
KARNATAKA |
9739868446
praveenkumarm1008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR.NAMAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K600||Acute 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: Gairikadya malahara , Reference: Rasatarangini , Route: Rectal, Dosage Form: Malahara/ Ointment/ Balm, Dose: 00(NA), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatadouta ghrita, Reference: Baishajya kalpana, Route: Rectal, Dosage Form: Ghrita, Dose: 00(NA), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age group of 16 to 70 year, patient of irrespective of sex and occupation, patients having clinical features of parikartika, patients with well controlled DM and HTN |
|
| ExclusionCriteria |
| Details |
Patients having complications like Malignancy of rectum and anal canal, TB,
Ulcerative colitis, Crohn’s disease will be avoided.
Patients with known cases of HIV, HBsAg, HCV.
Patients with sentinel pile and associated with conditions like Hemorrhoids,
Rectal prolapse and Fistula-in-Ano |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Presence of pain and burning sensation in anal region |
Before treatment and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Absence of pain and burning sensation in the anal region |
After treatment and 14th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
06/03/2025 |
| 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
|
The present study Titled " A COMPARATIVE CLINICAL STUDY OF GAIRIKADYA MALAHARA AND SHATADHAUTA GHRITA LEPA IN THE MANAGEMENT OF PARIKARTIKA W.S.R ACUTE FISSURE- IN- ANO" will be conducted on 60 subjects with 30 in each group with mentioned objective and subjective parameters. One group will be treated with GAIRIKADYA MALAHARA and another group with SHATADHAUTA GHRITA. assesment of patient will be done before the treatment and after treatment (14th day) |