| CTRI Number |
CTRI/2025/07/091804 [Registered on: 27/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to evaluate the efficacy of KVGAPs MEHACARE CAPSULE in Type II Diabetes Mellitus |
|
Scientific Title of Study
|
A SINGLE ARM OPEN LABEL NON-RANDOMISED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF KVGAP’S MEHACARE CAPSULE IN MADHUMEHA (TYPE II DIABETES MELLITUS) |
| 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 Gopalakrishna N Nayak |
| Designation |
Assistant Professor |
| Affiliation |
KVG Ayurveda Medical College and Hospital |
| Address |
OPD No.3, Kayachikitsa OPD
Department of Rasashastra & Bhaishajya Kalpana
KVG Ayurveda Medical College and Hospital Ambate adka Sullia
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9743643976 |
| Fax |
|
| Email |
nayak.gkn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopalakrishna N Nayak |
| Designation |
Assistant Professor |
| Affiliation |
KVG Ayurveda Medical College and Hospital |
| Address |
OPD No.3, Kayachikitsa OPD
Department of RAsashastra & Bhaishajya Kalpana
KVG Ayurveda Medical College and Hospital Ambate adka Sullia
KARNATAKA
574327
India |
| Phone |
9743643976 |
| Fax |
|
| Email |
nayak.gkn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gopalakrishna N Nayak |
| Designation |
Assistant Professor |
| Affiliation |
KVG Ayurveda Medical College and Hospital |
| Address |
OPD No.3, Kayachikitsa OPD
Department of RAsashastra & Bhaishajya Kalpana
KVG Ayurveda Medical College and Hospital Ambate adka Sullia
KARNATAKA
574327
India |
| Phone |
9743643976 |
| Fax |
|
| Email |
nayak.gkn@gmail.com |
|
|
Source of Monetary or Material Support
|
| KVG Ayurveda Pharma & Research Centre
Ambate adka, Sullia Taluk, Dakshina Kannada District, Karnataka- 574327 |
|
|
Primary Sponsor
|
| Name |
KVG Ayurveda Pharma and Research Centre |
| Address |
Ambate adka, Sullia Dakshina Kannada, Karnataka-574327 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Gopalakrishna N Nayak |
KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
OPD No.3, Kayachikitsa OPD
Department of RAsashastra & Bhaishajya Kalpana
KVG Ayurveda Medical College And Hospital, Sullia
Dakshina Kannada
KARNATAKA |
9743643976
nayak.gkn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS 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: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: MEHACARE CAPSULE, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Only uncomplicated cases of type-2 DM with FBS more than 126 mg/dl and less than 200 mg/dl.
2) With at least one of the following symptoms: Polyphagia, Polydypsia, Polyuria, Nocturnal micturition, Exhaustion/ Fatigue, Bodyache, Giddiness, Polyneuritis |
|
| ExclusionCriteria |
| Details |
1) Patients presenting with complications like severe renal disease, ischemic heart disease, severe hypertension etc.
2) Patients with type-1 DM
3) Patients outside the age group of 30-65 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Polyphagia, Polydypsia, Polyuria, Nocturnal micturition, Exhaustion/ Fatigue, Bodyache, Giddiness, Polyneuritis |
Baseline, After 15 days, After 30 Days, After 45 Days, After 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 1 |
|
Date of First Enrollment (India)
|
06/08/2025 |
| 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="4"
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
|
An open label non-randomized clinical trial will be
conducted with KVGAP’S MEHACARE CAPSULE for a purpose to evaluate its efficacy on Type
II Diabetes mellitus with the help of various Ayurvedic physicians. Thirty
patients of both sexes between the age group of 30-65 years, who are clinically
diagnosed as suffering from Type II Diabetes
mellitus and who were willing to give informed consent will be enrolled
in the study.
All
enrolled patients will undergo a through clinical examination and will be
assessed for subjective parameters: Polyphagia, Polydypsia, Polyuria, Nocturnal
micturition, Exhaustion/ Fatigue, Bodyache, Giddiness and Polyneuritis;
Objective parameters: FBS, PPBS & HbA1C. The patients will be advised to
take with KVGAP’S MEHACARE CAPSULE daily twice before food for a period of 2 months.
Follow up of patients will be conducted at baseline, at the end of 15 days. 30
days, 45 days and at the end of 60 days. Obtained data will be analyzed
statistically by relevant statistical test and efficacy is assessed. |