| CTRI Number |
CTRI/2019/01/017270 [Registered on: 25/01/2019] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
In Vivo and Clinical Study of Daruharidra Ghan Vati in Sthula Madhumeha that is Diabetes Mellitus |
|
Scientific Title of Study
|
In Vivo and Randomized Control Trial of Daruharidradi Ghanavati in Sthula Madhumeha with specific reference to Type II 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 |
SUSHIL VILAS CHAWRE |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurved College and Hospital, Sakkaradara Square, Raje Raghuji Nagar, Umred Road, Nagpur |
| Address |
Department of Kayachikitsa, Government Ayurved College and Hospital, Sakkaradara Square, Raje Raghuji Nagar, Umred Road, Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9923755771 |
| Fax |
07122749198 |
| Email |
sushilvilaschawre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PRAKASH RAMNARAYAN KABRA |
| Designation |
Professor |
| Affiliation |
Government Ayurved College and Hospital, Sakkaradara Square, Raje Raghuji Nagar, Umred Road, Nagpur |
| Address |
Department of Kayachikitsa, Government Ayurved College and Hospital, Sakkaradara Square, Raje Raghuji Nagar, Umred Road, Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9225226567 |
| Fax |
07122749198 |
| Email |
kabraprakash2711@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRAKASH RAMNARAYAN KABRA |
| Designation |
Professor |
| Affiliation |
Government Ayurved College and Hospital, Sakkaradara Square, Raje Raghuji Nagar, Umred Road, Nagpur |
| Address |
Department of Kayachikitsa, Government Ayurved College and Hospital, Sakkaradara Square, Raje Raghuji Nagar, Umred Road, Nagpur
MAHARASHTRA
440024
India |
| Phone |
9225226567 |
| Fax |
07122749198 |
| Email |
kabraprakash2711@gmail.com |
|
|
Source of Monetary or Material Support
|
| SELF ( SUSHIL VILAS CHAWRE) Department of Kayachikitsa,Government Ayurved College and Hospital, Sakkaradara Square, Raje Raghuji Nagar, Umred Road, Nagpur |
|
|
Primary Sponsor
|
| Name |
SUSHIL VILAS CHAWRE |
| Address |
Department of Kayachikitsa, Government Ayurved College and Hospital, Sakkaradara Square, Raje Raghuji Nagar, Umred Road, Nagpur |
| 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 |
| Sushil Vilas Chawre |
Government Ayurved college and hospital, Nagpur |
Department of Kayachikitsa
Government Ayureved college and hospital, Raje Raghuji Nagar, Umred Road , Sakkardara square, Nagpur
Nagpur
MAHARASHTRA |
9923755771
sushilvilaschawre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee,Government Ayurved College and Hospital, Sakkaradara Square, Raje Raghuji Nagar, Umred Road, Nagpur |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Daruharidradi Ghanavati |
‘Daruharidradi Ghanavati 500 mg twice in a day before lunch and dinner with leukwarm water for three months ’ will be given to patients in Trial Group |
| Comparator Agent |
Tablet Metformin 500mg
|
In control group Tablet Metformin 500mg will be given with lunch and dinner with water for three months. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. The patients having fasting plasma sugar level more than or equal to 126mg/dl and post prandial plasma sugar level more than or equal to 200mg/dl (A.D.A 2016)
2. The patients fulfilling criteria of diagnosis and having clinical features of Sthula Madhumeha (Diabetes Mellitus)
3. Patients having BMI more than 23Kg/m2 up to 30Kg/m2 will be selected.
4. HbA1c is 6.5%up to 10%.
5. Patients having age between 30years to 70 years.
6. Those are willing to participate in trial and ready to give their written consent. |
|
| ExclusionCriteria |
| Details |
1. Patients who already taking anti-diabetic drugs.
2. Patients with fasting plasma sugar level >250mg/dl and post meal plasma sugar level >350mg/dl.
3. Patients having insulin dependent diabetes mellitus and juvenile diabetes and various other types of diabetes except Type II DM.
4.Patients having BMI less than 23kg/m2 and More Than 30kg/m2.
5. HbA1c more than 10%.
6. Patients having age below 30 years and above 70 years.
7. Patients who are currently participating in any other clinical trials since last 6 months. 8. Patients having complications such as vasculopathy, nephropathy, retinopathy and neuropathy.
9. Patients having other systemic complications like hepatic, renal and cardiac problems.
10. Patients having poorly controlled blood pressure.
11. Pregnant and lactating females not included in this study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To study the effect of Daruharidradi Ghanavati in Streptozotocin induced diabetes Mellitus in Wister rats specifically on blood sugar level.
2.To study the effect of Daruharidradi Ghanavati on Sthula Madhumeha with specific reference to type II diabetes mellitus, on fasting and post prandial plasma sugar level and HbA1c,and to compare its effect with metformin. |
1.In Animal study-In Rats anti diabetic effect will be assessed after one month..
In Clinical trial -
1.On zero day i.e. before treatment value.
2.In trial group Daruharidradi Ghan Vati 500mg twice a day and in control group tablet Metformin 500mg twice a day will be given for 3months.
3.Follow up and assessment will be done on every 15days after starting medicine up to 90 days.
4.Final assessment will be done on ninety first day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the toxic effects of Daruharidradi Ghanavati by investigating LFT, KFT and relevant histo-pathological investigations in Swiss Albino mice.
2. To study the literature of Madhumeha as per Ayurvedic perspective. 3. To study the literature of Diabetes Mellitus. |
1.The oral chronic effect of Daruharidradi Ghan vati and Metformin in Swiss albino mice will be assess on ninety first day.
2. The assessment of all study will be evaluate after completion of study. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2019 |
| Date of Study Completion (India) |
30/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/12/2023 |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. The Standardization of Daruharidradi GHanvati Published in International Journal of Applied and Basic Medical Research by Wolters Kluwer- Medknow, Volume 14, January-March2024 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes Mellitus is a major public health challenge of the twenty-first century. Increasing Levels of Urbanization, Industrialization and economic advancement adversely affect the biological and environmental risk factors for Diabetes and other non-communicable diseases. Unhealthy diet, physical inactivity and stress factors cause overweight and insulin resistance1. This study entitled “In Vivo and Randomized Control Trial of Daruharidradi Ghanavati in Sthula Madhumeha with specific reference to Type II Diabetes Mellitus†All the parameters of assessment will be based on the signs and symptoms of Prameha mentioned in classics and the diagnostic criteria. Patients fulfilling the criteria will be selected and divided in two groups called trial and control group followed by a filling of consent form in language best understood by them. Control group patients will be administered by tab Metformin in a dose of 500 mg twice a day while in trial group patients will be going to manage with Daruharidradi Ghanavati as above mentioned dose and timing. All the parameters will be assessed before and after treatment based on the specially prepared proforma. Appropriate test will be applied to the data outcome and discussion and conclusion will be made accordingly. |