| CTRI Number |
CTRI/2016/08/007185 [Registered on: 16/08/2016] Trial Registered Retrospectively |
| Last Modified On: |
01/04/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of added effect of Dhatrinisha Vati in Madhumeha i.e.Diabetes Mellitus type- II |
|
Scientific Title of Study
|
Open labeled, active controlled, randomized evaluation of adjuvent effect of Dhatrinisha Vati in Madhumeha vis- a- vis Diabetes Mellitus type- II |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishali Deshpande |
| Designation |
Lecturer |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Sumatibhai Shah Ayurved Mahavidyalaya,
Malwadi, Hadapsar, Pune, Maharashtra
Pune
MAHARASHTRA
411028
India |
| Phone |
9096082950 |
| Fax |
02026999467 |
| Email |
dr.vaishalid@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrBhagyashri Bodake |
| Designation |
pg scholar |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Sumatibhai Shah Ayurved Mahavidyalaya,
Malwadi, Hadapsar, Pune, Maharashtra
A/P-Kharepatan(Rameshwarnagar) Tal-Kankavali
Dist-Sindhudurga
Sindhudurg
MAHARASHTRA
411028
India |
| Phone |
9637374196 |
| Fax |
|
| Email |
dr.bhagyashi555@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali Deshpande |
| Designation |
Lecturer |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Sumatibhai Shah Ayurved Mahavidyalaya,
Malwadi, Hadapsar, Pune, Maharashtra
Pune
MAHARASHTRA
411028
India |
| Phone |
9096082950 |
| Fax |
02026999467 |
| Email |
dr.vaishalid@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Maharashtra Arogya Mandals Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Malwadi, Hadapsar, Pune - 411028 |
| Type of Sponsor |
Private medical college |
|
|
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 Vaishali Deshpande |
Maharashtra Arogya Mandals Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
OPD No. 1 and 2 Department of Kayachikitsa
Pune
MAHARASHTRA |
9096082950
02026999467
dr.vaishalid@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| nstitutional Ethics Committee, Maharashtra Aarogya Mandal’s Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi , Hadapsar, Pune-28 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Antidiabetic agents(Oral hypoglycaemic agents) |
Only allopathic antidiabetic agents(Oral hypoglycaemic agents)in required doses frequency will be admistered for 90 days |
| Intervention |
Dhatri Nisha Vati |
Dhatri Nisha Vati orally in the dose of 1gm tds will be administered along with conventional antidiabetic medicines(Oral hypoglycaemic agents) for 90 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. A known diabetic on treatment and a newly diagnosed diabetic.
2. Patients presenting classical symptoms of Madhumeha.
3. Patient with fasting blood sugar up to 220 mg% and post prandial blood sugar up to 300 mg%.
4. Patient showing good, fair and moderate control in HbA1c test.
5. Patients having fasting blood sugar in between 221 to 250 and post prandial 301 to 400 and if they are having good, fair, moderate control in HbA1C and normal fundoscopy.
|
|
| ExclusionCriteria |
| Details |
1.Patients with fasting blood sugar above 220 mg% and post prandial blood sugar above 300mg%.
2.Diabetes Mellitus Type-I and those who are under insulin therapy.
3.Pregnant and lactating mothers, known cases of Gestational Diabetes.
4.Patients with acute complications like Hyperglycemic coma, Ketoacidosis, and infections like gangrene.
5.Patients with chronic complications like Nephropathy, Neuropathy and Retinopathy.
6.Patients suffering from other diseases such as Tuberculosis, Cardiac diseases, HIV.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Assessment of pre and post treatment changes in HbA1c % (Glycosylated Hemoglobin
%) values.
2. Assessment of change in blood sugar fasting and post prandial levels
3. Assessment of efficacy on the basis of subjective parameters
|
1. At base line and at the end of 3 Months.
2. 0, 30, 60, 90 Days
3. 0, 30, 60, 90 Days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of change in Body weight |
0, 30, 60,90 days |
| Assessment of change in B.M.I |
0, 30, 60, 90 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
20/01/2016 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an open labeled, active controlled,randomized prospective, clinical study to evaluate the adjuvant effect of DhatriNisha Vati in Type II Diabetic Patients.The drug Dhatri Nisha Vati will be given in a dose of 1 gm Three times in a day orally before meals for 90 days. the conventional antidiabetic medications which patients are taking previously will be continued. The primary outcome measures will be assessment of pre and post treatment changes in HbA1c % (Glycosylated Hemoglobin %) values and monthly assessment of changes in fasting & postprandial plasma glucose levels. The secondary outcomes will be assessment of weight, B.M.I. at baseline and every 30 days upto 90 days, assessment of clinical symptoms of diabetes, assessment of changes in dose of OHAs.
|