| CTRI Number |
CTRI/2024/07/070885 [Registered on: 19/07/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Efficacy study] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study on the Antidiabetic Benefits of Mehanil Plus Tablets for People with Type 2 Diabetes |
|
Scientific Title of Study
|
A Randomoized, Two-Arm Pilot Study Evaluating Mehanil Plus Tablets in Type Two Diabetes: Biochemical and Quality Parameters Assessment |
| 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 Sheela Karalam B |
| Designation |
Consultant |
| Affiliation |
Vaidyaratnam Ayurveda Research Institute |
| Address |
R&D Department
Room No. 3
Vaidyaratnam Ayurveda research Institute
Thrissur
KERALA
680306
India |
| Phone |
9446533770 |
| Fax |
|
| Email |
sheelakaralam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashi Augustine |
| Designation |
Consultant |
| Affiliation |
Vaidyaratnam Ayurveda Research Institute |
| Address |
R&D Department
Room No. 1
Vaidyaratnam Ayurveda research Institute
Thrissur
KERALA
680306
India |
| Phone |
7025168188 |
| Fax |
|
| Email |
ashmarry15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dileep K S |
| Designation |
Consultant |
| Affiliation |
Vaidyaratnam Ayurveda Foundation Hospital |
| Address |
Speciality clinical department
Room No. 2
Vaidyaratnam Ayurveda Foundation Hospital
Thrissur
KERALA
680306
India |
| Phone |
9961045901 |
| Fax |
|
| Email |
dileepkshankar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidyaratnam Ayurveda Foundation Hospital
Ollur, Thaikkattussery
Thrissur - 680306
kerala, India |
|
|
Primary Sponsor
|
| Name |
Dr Sheela Karalam B |
| Address |
Vaidyaratnam Ayurveda Research Institute
Ollur, Thaikkattussery, Thrissur-680306, Kerala, India |
| Type of Sponsor |
Other [self] |
|
|
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 Dileep K S |
Vaidyaratnam Ayurveda Foundation Hospital |
Speciality clinic
Out patient department
Ollur Thaikkattussery, Thrissur - 680306
Thrissur
KERALA |
9961045901
dileepkshankar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional committee for ethics in research |
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 | Other than Classical | | (1) Medicine Name: mehanil plus, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 650(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo | Carboxymethyl cellulose Sodium, Micro crystalline cellulose powder, Dicalcium phosphate.
Route: oral, Dosage form: Tablet, Dose: 650mg, Frequency: bd, Bhaishajyakala: Pragbhakta, Duration: 45 days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Individuals diagnosed with hyperglycemia and currently
undergoing treatment with Metformin tablets will be considered for study and comparison will be done between the impact of Mehanil plus tablet and placebo in the management of Diabetes type 2 |
|
| ExclusionCriteria |
| Details |
Participants diagnosed with Type 1 Diabetes Mellitus.
Participants who are known cases of other chronic systemic illness.
Type 2 Diabetes Mellitus patients with complications.
Participants who are known cases of psychiatric illness.
Pregnancy and Lactating women.
Participants having completed any other trail within past 6 months |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Anticipated favorable outcomes by comparing biochemical parameters at baseline, 21st and end of the study
Biochemical parameters:
FBS, HbA1C, OGTT, S insulin level, Lipid profile, C Peptide level, HOMA-IR,B,BMI, HB, LFT, RFT, QOLID
|
Time points: Baseline, 21st day and 45th day
Baseline - FBS, HbA1C, OGTT, S insulin level, Lipid profile, C Peptide level, HOMA-IR,B,BMI, HB, LFT, RFT, QOLID
21st day - FBS, OGTT, S insulin level, Lipid profile, C Peptide level ,BMI, HB
45th day - FBS, HbA1C, OGTT, S insulin level, Lipid profile, C Peptide level, HOMA-IR,B,BMI, HB, LFT, RFT, QOLID
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Expected an improvement in Quality of life by comparing baseline & 45th day interrogation by means of Ayurveda symptomatic relief & QOLID questionnaire. Based on the results of the study, effectiveness of Mehanil plus can be provided to the community. |
0th day, 21st day, 45th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
29/07/2024 |
| Date of Study Completion (India) |
05/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Background : Type 2 diabetes is a chronic metabolic disorder characterized by insulin resistance and insufficient insulin production, leading to elevated blood sugar levels. In Ayurveda, Type 2 diabetes correlates with Prameha, involving kleda and kapha, and marked by frequent, turbid urination.The aetiology of diabetes in India is multi-factorial and includes genetic factors coupled with environmental influences such as obesity associated with rising living standards, and lifestyle changes. Various treatment options are available, but the quest for safer and more effective anti-diabetic agents continues. Purpose of the Trial: This pilot trial aims to evaluate the anti-diabetic efficacy of Mehanil Plus, an Ayurvedic proprietary medicine by Vaidyaratnam Group, containing a blend of herbs. Mehanil Plus tablets will be administered at 650 mg (two tablets) twice daily before food to 30 subjects in which the patients are already under antidiabetic product ie, Metformine. Quality of Life (QOLID) assessments and specific lab tests will be conducted on the first, 21st, and 45th days. The data will be analyzed for statistical significance to assess the potential of Mehanil Plus as an effective adjuant therapy for Type 2 diabetes. |