| CTRI Number |
CTRI/2025/02/080640 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To test tablets for Diabetes. |
|
Scientific Title of Study
|
An Open Label, Single Arm Clinical Study to Evaluate the safety and efficacy of Shuddhi Dr. Madhumeh tablets in patients suffering from Diabetes |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MGCTS/24/400 Version 1.0 dated 20 Dec 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakhi Mehra |
| Designation |
Principal Investigator |
| Affiliation |
GS Ayurveda Medical College and hospital |
| Address |
GS Ayurveda Medical College and hospital, Pilkhuwa Ghaziabad Uttar Pradesh 245304 India
Ghaziabad
UTTAR PRADESH
245304
India
Ghaziabad
UTTAR PRADESH
245304
India |
| Phone |
9868965688 |
| Fax |
|
| Email |
raakhimehra49@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
Mittal Building- MAS
121-B, Vishwakarma Industrial Estate Extn., Baghpat Road, Panchli, Meerut-250005
Meerut
UTTAR PRADESH
250002
India |
| Phone |
08937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
Mittal Building- MAS
121-B, Vishwakarma Industrial Estate Extn., Baghpat Road, Panchli, Meerut-250005
Mittal Building- MAS
121-B, Vishwakarma Industrial Estate Extn., Baghpat Road, Panchli, Meerut-250005
Meerut
UTTAR PRADESH
250002
India |
| Phone |
08937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| Jeena Sikho Lifecare Limited Kalgidhar Enclave, Baltana, Zirakpur, Mohali Punjab 140604 |
| Mittal Global Clinical Trial Services: MGCTS, Mittal Building- MAS 121-B, Vishwakarma Industrial Estate Extn., Baghpat Road, Panchli, Meerut-250005 Meerut |
|
|
Primary Sponsor
|
| Name |
Jeena Sikho Lifecare Limited |
| Address |
Kalgidhar Enclave, Baltana, Zirakpur, Mohali Punjab 140604 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakhi Mehra |
GS AYURVEDA MEDICAL COLLEGE & HOSPITAL |
Rooma no- 2NH-9, VILLAGE PEEPLABANDPUR, PILKHUWA, DISTT. - HAPUR (U.P.) - 245304
Ghaziabad
UTTAR PRADESH
Ghaziabad
UTTAR PRADESH |
9868965688
raakhimehra49@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GS AYURVEDA MEDICAL COLLEGE & HOSPITAL IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E109||Type 1 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shuddhi Dr. Madhumeh tablets, Reference: Ayurveda Sangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Not Applicable), Additional Information: Duration: 1 tablet BD, 30 mins before meal-: 1 tablet BD, 30 mins before meal |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject from 18 to 65 years of age.
2. Subject suffering from Diabetes with Fasting Blood Glucose level below 200 mg/dl.
3. If female with childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study.
4. Subject that are able to give written informed consent in a manner approved by the institutional ethics committee and comply with the requirements of the study.
5. Subject willing to avoid participation in any other interventional clinical trial for the duration of the study.
|
|
| ExclusionCriteria |
| Details |
1. Females that are pregnant, breast feeding, or planning to get pregnant during the study.
2. Subject on insulin.
3. Subject that have participated in any other interventional clinical trial in the previous 90 days.
4. Subject with known sensitivity to any of the constituents of the investigational product. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy of Shuddhi Dr Madhucare Tablets
1. Change in HbA1c
2. Change in CBC
3. Change in Urine Routine |
Day 1, Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
study the quality of life by.
1. QOL(SF-36)
2. SGA
|
Day 1, Day 30, Day 60 and Day 90 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
27/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
An Open Label, Single Arm Clinical Study to Evaluate the safety and efficacy of Shuddhi Dr Madhucare Tablets in patients suffering from Diabetes.
From age 18 years to 65 years of age.
The subjects will take 1 tablet 30 mins before meal two times a day with lukewarm water for the duration of 90 days.
|