| CTRI Number |
CTRI/2024/06/068961 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of Mehmudgar Vati in the management of Madhumeha W.S.R. To Type -2 Diabetes Mellitus
|
|
Scientific Title of Study
|
Preclinical & Clinical evaluation Of Safety And Efficacy Of Mehmudgar Vati In The Management Of Madhumeha With Special reference To type 2 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 |
Babulal |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Ayurveda Deemed to be University, Jaipur |
| Address |
Department of Kaya Chikitsa National Institute of Ayurveda Deemed to be University,Johwara Singh Gate, Aamer Road Jaipur-
Jaipur
RAJASTHAN
302002
India |
| Phone |
07976499082 |
| Fax |
|
| Email |
drbabulal85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof (Dr.) Ram Kishor Joshi |
| Designation |
Professor and Head |
| Affiliation |
National Institute of Ayurveda Deemed to be University, Jaipur |
| Address |
Department of Kaya Chikitsa National Institute of Ayurveda Deemed to be University,Johwara Singh Gate, Aamer Road Jaipur-
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414322297 |
| Fax |
|
| Email |
joshirk1964@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Babulal |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Ayurveda Deemed to be University, Jaipur |
| Address |
Department of Kaya Chikitsa National Institute of Ayurveda Deemed to be University,Johwara Singh Gate, Aamer Road Jaipur-
RAJASTHAN
302002
India |
| Phone |
07976499082 |
| Fax |
|
| Email |
drbabulal85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 57 Department of Kayachikitsa OPD 1 National Institute of Ayurveda deemed University Amer Road Near Jorawar Singh Gate Jaipur 302002 Rajashtan India |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda,Johwrawar Singh Gate, Aamer Road, Jaipur 302002 Rajasthan India |
| Type of Sponsor |
Research institution |
|
|
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 |
| Prof Ramkishor Joshi |
National Institute of Ayurveda |
National Institute of Ayurveda, Johwar Singh Gate, Aamer Road Jaipur
Jaipur
RAJASTHAN |
9414322297
joshirk1964@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe National institute of Ayurvedae |
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 | Classical | | (1) Medicine Name: Mehmudagar vati, Reference: Bhaishajya Ratnavali Prameha Rogadhikara 37/75-78, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: -Twice in a day, before meal | | 2 | Comparator Arm (Non Ayurveda) | | - | Metformin | Metformin 500 mg in twice a day with
lukewarm water before meal for 90 days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient ready to give consent for trial and willing to participate in the study
2. Patients between the age group of 30-60 years in either sex.
3. Patients with Fasting Blood Sugar (FBS) in the range of 126mg/dl – 200mg/dl or/and
Post Prandial Blood Sugar (PPBS) in the range of 200mg/dl – 250 mg/dl.
4. Newly diagnosed case of Madhumeha (Type 2 diabetes mellitus).
5. Presence of Cardinal symptoms of Diabetes Mellitus eg. (3P- polyuria, polydipsia,
polyphagia). |
|
| ExclusionCriteria |
| Details |
1. Patient not willing to sign the consent form.
2. Patients having Type-1 Diabetes Mellitus.
3. Patients of Type -2 Diabetes Mellitus who are on insulin therapy and Drug induced
Diabetes Mellitus.
4. DM with complications and Madhumeha with asadhya upadrava.
5. Patients having any serious illness like cardiovascular diseases, renal diseases, hepatic
diseases, acute/ chronic pancreatitis, malignancy, any other endocrinopathies .
6. Pregnant and lactating mother.
7. Patient on any other medications which may interfere with the effect of intervention.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in the objective parameters- F.B.S., P.P.B.S. HbA1c from
baseline value. |
18 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in the clinical symptoms of Mahdumeha (Type 2 diabetes
mellitus)
Prabhoot Mutrata (Polyuria),Avila Mutrata (Turbidity of urine),Trishnaadhikya ( Polydypsia),Kshudhadhikya (Polyphagia),Mukha Shosha ( Dryness of
Mouth),Vibandha (Constipation),Hastapada & Sandhi Shula (Pain in
hands, feet & joints ),Kar Pada Daha (Burning sensation
in hands & feet),Kara Pada Supti (Numbness of
Extremities),Daurbalya (Weakness),Klama (Fatigue) |
90 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
AIM To evaluate the efficacy of Mehmudgara vati in Diabetes mellitus w.s.r to Madhumeha OBJECTIVES: 1. Pre-clinical Study: a. To evaluate the safety and efficacy of Mehmudgara Vati in Alloxan induced diabetes mellitus in wistar albino rats. b. To assess the effect of Mehmudgara Vati in beta cells (Islets of Langerhans) of Pancreas through histopathological examination of the pancreatic cells in Alloxan induced diabetes mellitus in wistar albino rats. 2. Clinical Trial: 45 Primary Objectives: 1. To evaluate and compare the effect of Mehmudgar Vati on blood glucose level (FBS, PPBS) and HbA1c in Type -2 Diabetes Mellitus (Madhumeha) patients. Secondary Objectives: 2. To evaluate the effect of Mehmudgara vati on symptoms of Type -2 Diabetes Mellitus (Madhumeha). HYPOTHESIS: ï‚· Null Hypothesis (Ho): There is no difference between effect of Mehmudgar Vati and Metformin in the management of Madhumeha w.s.r. to Type -2 Diabetes Mellitus. ï‚· Alternative Hypothesis (HA): There is difference between effect of Mehmudgar Vati and Metformin in the management of Madhumeha w.s.r. to Type -2 Diabetes Mellitus. |