| CTRI Number |
CTRI/2024/12/078511 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Gambhari phal in acute urticaria |
|
Scientific Title of Study
|
Randomised comparative clinical study of Gambhari phal ( Gmelina arborea linn) with and without pathya in sheetpitta with special reference to acute urticaria |
| 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 Aniket Joshi |
| Designation |
Asso. Professor |
| Affiliation |
LRP Ayurved Medical College and Hospital, Post Graduate and Institute and Reseach centre,Islampur |
| Address |
opd no. 1 Lokanete Rajarambapu Patil Ayurved Medical College and Hospital, Post Graduate and Institute and Reseach centre,Islampur, Tal - Walwa
Dist Sangli 415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
9890890889 |
| Fax |
|
| Email |
vdaniket@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aniket Joshi |
| Designation |
Asso. Professor |
| Affiliation |
LRP Ayurved Medical College and Hospital, Post Graduate and Institute and Reseach centre,Islampur |
| Address |
opd no. 1 Lokanete Rajarambapu Patil Ayurved Medical College and Hospital, Post Graduate and Institute and Reseach centre,Islampur, Tal - Walwa
Dist Sangli 415409
MAHARASHTRA
415409
India |
| Phone |
9890890889 |
| Fax |
|
| Email |
vdaniket@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aniket Joshi |
| Designation |
Asso. Professor |
| Affiliation |
LRP Ayurved Medical College and Hospital, Post Graduate and Institute and Reseach centre,Islampur |
| Address |
opd no. 1 Lokanete Rajarambapu Patil Ayurved Medical College and Hospital, Post Graduate and Institute and Reseach centre,Islampur, Tal - Walwa
Dist Sangli 415409
MAHARASHTRA
415409
India |
| Phone |
9890890889 |
| Fax |
|
| Email |
vdaniket@gmail.com |
|
|
Source of Monetary or Material Support
|
| opd no. 1 Lokanete Rajarambapu Patil Ayurved Medical College and Hospital, Post Graduate and Institute and Reseach centre,Islampur, Tal - Walwa
Dist Sangli 415409 |
|
|
Primary Sponsor
|
| Name |
Punam Navnath Pawar |
| Address |
opd no. 1 Lokanete Rajarambapu Patil Ayurved Medical College and Hospital, Post Graduate and Institute and Reseach centre,Islampur, Tal - Walwa Dist Sangli 415409 |
| 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 Punam Navnath Pawar |
LRP Ayurveda Hospital, Islampur |
opd no. 1 Lokanete Rajarambapu Patil Ayurved Medical College and Hospital, Post Graduate and Institute and Reseach centre,Islampur, Tal - Walwa Dist Sangli 415409
Sangli
MAHARASHTRA |
9373301700
poonampawar40644@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Loknete Rajarambapu Patil Ayurved Mahavidyalay Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L500||Allergic urticaria. Ayurveda Condition: SITAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gambhari phal, Reference: Yog Ratnakar, Route: Oral, Dosage Form: Kalka/ Paste , Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -cow milk), Additional Information: -with pathya | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gambhari phal, Reference: Yog Ratnakar, Route: Oral, Dosage Form: Kalka/ Paste , Dose: 30(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -cow milk), Additional Information: -without pathya |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The patient will be selected irrespective of gender, religion, occupation, marital status.
Patients with classical symptoms of Sheetpitta Viz Mandala, Utsedha, Toda, Daha, Kandu, Chardi are included in our study.
Patients with acute Urticaria(It lasts for less than six weeks).
Patients above the age of 16 years and below the age of 60 years. |
|
| ExclusionCriteria |
| Details |
Drug induced Urticaria.
Patients having history of any chronic diseases .e.g. Heart diseases, paraplegia, diabetes mellitus, hypertensive, Cronic kidney disease etc.
Patients having the symptom of Jwara are excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| With pathya gambhari phal is more effective in sheetpitta |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Without pathya gambhari phal is more effective in sheetpitta |
30 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
15/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/01/2025 |
| 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
|
Regardless of wide research , detail understanding and treatment modalities it still remains to be cause of concern due to its recurrent nature. In this study of Randomised comparative clinical study to evaluate the efficacy of Gambhari Phal with and without pathya in sheetpitta ,80 patient will be taken divided by 2 equal groups .One group will be given Gambhari phal with pathya while other will be given Gambhari phal without pathya and further research will be concluded. |