| CTRI Number |
CTRI/2020/02/023347 [Registered on: 14/02/2020] Trial Registered Prospectively |
| Last Modified On: |
13/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role Of Vanga Bhasma With Phaltrikadi Kwath in Diabetes Mellitus |
|
Scientific Title of Study
|
"Pharmaceutico analytical and clinical study of Vanga Bhasma with phaltrikadi kwath W.S.R. to Madhumeha (D.M.)" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vipul Verma |
| Designation |
PG Scholar |
| Affiliation |
Shubhdeep Ayurveda Medical College & P.G Institute |
| Address |
Shubdeep ayurveda medical college village datoda, khandwa road indore
Indore
MADHYA PRADESH
452020
India |
| Phone |
9009021008 |
| Fax |
|
| Email |
vplvarma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhilesh Shrivastava |
| Designation |
Professor |
| Affiliation |
Shubhdeep Ayurveda Medical College & P.G Institute |
| Address |
Shubdeep ayurveda medical college village datoda, khandwa road indore
Indore
MADHYA PRADESH
452020
India |
| Phone |
9993281713 |
| Fax |
|
| Email |
drshrivastava.akhilesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ak singh |
| Designation |
Professor |
| Affiliation |
Shubhdeep Ayurveda Medical College & P.G Institute |
| Address |
Shubdeep ayurveda medical college village datoda, khandwa road indore
Indore
MADHYA PRADESH
452020
India |
| Phone |
9306681233 |
| Fax |
|
| Email |
doctoraksingh@yahoo.com |
|
|
Source of Monetary or Material Support
|
| shubhdeep Ayurveda Medical college and P.G institute gram datoda khandwa road indore
pin code- 452020 |
|
|
Primary Sponsor
|
| Name |
Shubhdeep Ayurveda Medical College Hospital Indore |
| Address |
Shubhdeep Ayurveda Medical College Hospital gram datoda khandwa road Indore 452020 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vipul Verma |
Shubhdeep ayurveda medical college and hospital |
village datoda khandwa road indore madhya pradesh
Indore
MADHYA PRADESH |
9009021008
vplvarma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
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 |
vanga bhasma |
group A vanga bhasma 125 mg with madhu BD FOR 30 DAYS BEFORE MEAL and group b vanga bhasma 125 mg with madhu and anupan phaltrikadi kwath BD FOR 30 DAYS BEFORE MEAL |
| Comparator Agent |
Vanga bhasma |
vanga bhasma 125 mg with madhu BD for 30 days before meal
|
| Comparator Agent |
vanga bhasma with phaltrikadi kwath |
vanga bhasma 125 mg with madhu and anupan phaltrikadi kwath BD FOR 30 DAYS BEFORE MEAL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Diabetes mellitus type 2 in Non-obese patients
2 Patients between the age group of 30-70 years with irrespective of gender
3 Patients willing to participate in the study period of 45 days
4 FBS more than 110 mg/dl and PPBS more than 140 mg/dl or both
5 BMI less than 25 kg/m2 |
|
| ExclusionCriteria |
| Details |
1 Diabetes mellitus type 2 in obese patients
2 Patients of IDDM
3 Patients age less than 30 years and more than 70 years
4 patients of gestational diabetes, juvenile diabetes , malignancy T.B gangrene and any other complications of diabetes
5 patients with an evidence of suffering from any severe systemic disease
6 FBS less than 110 mg/dl and PPBS less than 140 mg/dl |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
after giving vanga bhasma for 30 days in both the groups all criteria will be assesd on the basis of lakshan given below
1) Relief in prabhuta mutrata
2) relief in pipasa
3) relief in kshudha
4) reilef in daurbalyata
4) relief in daurbalyata
5) relief in karpadadaha |
30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
after completion of treatment for 30 days patient will be assesed at the 60 th day in both the groups
1) Relief in prabhuta mutrata
2) relief in pipasa
3) relief in kshudha
4) reilef in daurbalyata
4) relief in daurbalyata
5) relief in karpadadaha |
60 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 4 |
|
Date of First Enrollment (India)
|
15/02/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Among all endocrinological diseases, Diabetes Mellitus is serious global health problem. It is one of the burning problems of our society’s life style disorder, which is seen in all age group. Ayurveda has recommended number of drugs from indigenous herbal sources and from Rasashtra especially drugs of mineral, metals and animal’s origin for the treatment of Madhumeha and have been succesful in controlling the disease as well. A huge variety of medicinal plants, minerals, metals preprations have been reported to possess anti-diabetic effects. Therefore the search for more effective and safe hypoglycemic agent has continued to be an important area of active research.. The hypoglycemic activity of Vanga bhasma has been proved clinically. but yet the mode of Vanga bhasma with Phaltrikadi kwath(Synergistic efect) is not revealed. Hence the present study is planned to evaluate the Hypoglycemic and Synergistic effect of Vanga bhasma & Phaltrikadi kwath on Non-Obese Madhumeha (Diabetes Mellitus) patients. |