| CTRI Number |
CTRI/2024/08/073141 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
procedure to study effect of Palasha Beeja( Butea Monosperma) in Sugar/Diabetese patient( Prameha) |
|
Scientific Title of Study
|
A study of Phytopharmacognostic and Clinical Efficacy of Palasha Beeja (Butea monosperma Lan-kutze) in prameha W.S.R.Diabetes Mellitus-2 |
| 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 Anuj Jain |
| Designation |
PG scholar |
| Affiliation |
Shri shivayogeeshwar Rural Ayurvedic Medical College Hospital and Research Centre Inchal |
| Address |
SSRAMCH, PG scholar room no 2,dept of Dravya guna
Belgaum
KARNATAKA
591102
India |
| Phone |
9926268555 |
| Fax |
|
| Email |
anujayurved@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Drakshayani N Benni |
| Designation |
Guide |
| Affiliation |
Shri shivayogeeshwar Rural Ayurvedic Medical College Hospital and Research Centre Inchal |
| Address |
Guide chamber room no 1/dept of Dravya guna
Inchal
Belgaum
KARNATAKA
591102
India |
| Phone |
9535699454 |
| Fax |
|
| Email |
dr.drakshi@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuj Jain |
| Designation |
PG Scholar |
| Affiliation |
Shri shivayogeeshwar Rural Ayurvedic Medical College Hospital and Research Centre Inchal |
| Address |
PG scholar room no 2, Department of Dravya guna
Belgaum
KARNATAKA
591102
India |
| Phone |
9926268555 |
| Fax |
|
| Email |
anujayurved@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Shivayogeeshwar Rural Ayurvedic Medical Collage Hospital and PG Research Centre Inchal 591102 Savadatti Taluka,Belt
Shri Shivayogeeshwar Rural Ayurvedic Medical College, Hospital and PG Research Centre Inchal 591102, Belgavi
Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Anuj Jain |
| Address |
Shri Shivayogeeshwar Rural Ayurvedic Medical College Hospital and Research Centre Inchal 591102 Savadatti Taluka ,Belagavi Karnataka |
| Type of Sponsor |
Other [PG Scholar] |
|
|
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 Anuj jain |
Shri shivayogeeshwar Rural Ayurvedic medical college Hospital and Research centre ,Inchal |
Department of Dravya Guna,
SSRAMCH Hospital OPD, Inchal, 591102, Taluka Savadatti
Belgaum
KARNATAKA |
9926268555
anujayurved@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SSRAMCH Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Palash beeja Ghan vati, Reference: Vaidya sahchar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: -nil |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
FBS Level 126mg/dl or higher, post lunch blood sugar 200mg/dl or higher
urine sugar level fasting and post prandial
patient ready to sign informed consent form |
|
| ExclusionCriteria |
| Details |
Patients of age less than 25 years and more than 60 years and pregnant ladies, FBS more than 300mg/dl and post lunch blood sugar more than 400mg/dl were excluded, |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in fasting blood sugar and PPBS |
On 0th day before beginning of treatment,30th day after completion of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
05/09/2024 |
| 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="15" |
|
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
|
The trial for PG thesis and it is a single arm study in PRAMEHA , the title is " A STUDY OF PHYTOPHARAMACOGNOSTIC & CLINICAL EFFICACY OF PALASHA BEEJA ( Butea monosperma Lan-Kutze) IN PRAMEHA WSR DIABETES MELLITUS - II" Total of 40 patients will be enrolled , PALASHA BEEJA GHAN VATI 500mg will be given for 30 days , The effect will be noted and tested statistical, test will be done for testing of hypothesis and conclusion will be drawn,the subjective criteria will be used for assessment |