| CTRI Number |
CTRI/2021/07/035291 [Registered on: 30/07/2021] Trial Registered Prospectively |
| Last Modified On: |
15/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Trial to study the effect of two drugs, Bhumyamalaki and Kali Maricha in patients with Diabetes Mellitus (Madhumeha) |
|
Scientific Title of Study
|
A Clinical Study to evaluate the effect of combination of Bhumyamalaki ( Phyllanthus niruri) and Kali Maricha ( Piper nigrum) on Madhumeha WSR to Diabetes Mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rosy Gupta |
| Designation |
Reader |
| Affiliation |
Post Graduate Training and Research Institute Government Ayurvedic College Patiala |
| Address |
Reader in Post Graduate Training and Research Institute Government Ayurvedic College Patiala
Post Graduate Training and Research Institute Government Ayurvedic College Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9815818190 |
| Fax |
|
| Email |
rrgu04@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr BK Sharma Kaushik |
| Designation |
Vice Chancellor |
| Affiliation |
Guru Ravidas Ayurved University, Hoshiarpur, Punjab- 146001 |
| Address |
Guru Ravidas Ayurved University, Hoshiarpur, Punjab- 146001
Guru Ravidas Ayurved University, Hoshiarpur, Punjab- 146001
Hoshiarpur
PUNJAB
146001
India |
| Phone |
9463369477 |
| Fax |
|
| Email |
acharyakaushik54@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rosy Gupta |
| Designation |
Reader |
| Affiliation |
Post Graduate Training and Research Institute Government Ayurvedic College Patiala |
| Address |
Reader in Post Graduate Training and Research Institute Government Ayurvedic College Patiala
Post Graduate Training and Research Institute Government Ayurvedic College Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9815818190 |
| Fax |
|
| Email |
rrgu04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Training and Research Institute Government Ayurvedic College Patiala |
|
|
Primary Sponsor
|
| Name |
Post Graduate Training and Research Institute Government Ayurvedic College Patiala |
| Address |
Post Graduate Training and Research Institute Government Ayurvedic College Patiala Punjab |
| 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 Monika |
Post Graduate Training and Research Institute Government Ayurvedic College Patiala |
Dravyaguna Department Post Graduate Training and Research Institute Government Ayurvedic College Patiala Punjab
Patiala
PUNJAB |
9888246484
drmonika7076@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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: MADHUMEHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bhumyamalaki and Kali maricha, Reference: Yog Ratanakar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: Bhumyamalaki dose-6 gm TID
Kali marich dose - 7 kali maricha in raw form coverted into churan form wth dose 500mg TID. |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient who will give written consent.
Patient having clinical features of Madhumeha according to Ayurvedic Classics.
Patient who are on oral hypoglycemic drugs but still having hyperglycemia. |
|
| ExclusionCriteria |
| Details |
Patient who are insulin dependent.
Patient below 30 years and high chances of being DM type -1.
Gestational Diabetes Mellitus, Pregnancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Assess the subjective symptoms like:
Prabhoota mutrata (polyuria)
Avila mutrata (Turbid urine)
Sthulata (Weight gain)
Shrama ( Fatigue)
|
1st day
8th day
15th day
30th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the objective parameter like:
Blood sugar level |
1st day
8th day
15th day
30th day |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/07/2021 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drmonika7076@gmail.com].
- For how long will this data be available start date provided 30-07-2021 and end date provided 30-07-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Diabetes Mellitus is a clinical syndrome characterized by hyperglycemia due to absolute or relative deficiency of insulin. It is a leading cause of morbidity and mortality all over the world . The Prevalence of DM in India is currently reported to be around 13-15% and by 2025 it is estimated that approximately 55 million Indians will be Diabetic. The properties of Bhumyamalaki and Kali maricha drug have potential to treat the Madhumeha/DM more efficiently. 1. Total patients - 60 2. Group - I & II 3. Present title- "A Comparative clinical study to evaluate the efficacy of Bhumyamalaki Churna and Kali Maricha Churna on Madhumeha w s r to Diabetes Mellitus". 4. Both drugs will be given for 30 days and will be analyzed on the basis of subjective and objective criteria. |