CTRI Number |
CTRI/2015/04/005719 [Registered on: 24/04/2015] Trial Registered Retrospectively |
Last Modified On: |
24/04/2015 |
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
|
Clinical Study of the effect of Vidangadi Ghanavati in Prameha (Diabetes Mellitus Type II). |
Scientific Title of Study
|
Open labelled, active controlled, randomized evaluation of the effect of Vidangadi Ghanavati in Prameha 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 Shailesh Vinayak Deshpande |
Designation |
Lecturer |
Affiliation |
PDEAs College of Ayurved and Research Centre |
Address |
Sector 25, Pradhikaran, Nigadi,
Pune 411044 Sector 25, Pradhikaran, Nigadi,
Pune 411044 Pune MAHARASHTRA 411044 India |
Phone |
9763104451 |
Fax |
|
Email |
dr.shaileshd@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shailesh Vinayak Deshpande |
Designation |
Lecturer |
Affiliation |
PDEAs College of Ayurved and Research Centre |
Address |
Sector 25, Pradhikaran, Nigadi,
Pune 411044 Sector 25, Pradhikaran, Nigadi,
Pune 411044 Pune MAHARASHTRA 411044 India |
Phone |
9763104451 |
Fax |
|
Email |
dr.shaileshd@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DrKrutika Jadhav |
Designation |
PG Student and Co-Inestigator |
Affiliation |
PDEAs College of Ayurved and Research Centre |
Address |
Sector 25, Pradhikaran, Nigadi,
Pune 411044 Sector 25, Pradhikaran, Nigadi,
Pune 411044 Pune MAHARASHTRA 411044 India |
Phone |
9967910927 |
Fax |
|
Email |
dr.krutikajadhav@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
PDEAs College of ayurved and research centre nigdi pune |
Address |
College of Ayurved and Research Centre, Sector 25, Pradhikaran, Nigadi, Pune 411044 |
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 Shailesh Vinayak Deshpande |
Department of Kayachikitsa, opd no 117 |
Opd no.117,Kayachikitsa department, PDEAs Ayurved Rugnalaya and Sterling Multispeciality Hospital, Sector 27, Near Bhel Chowk, Nigadi, Pradhikaran, Pune 411044 Pune MAHARASHTRA |
9763104451
dr.shaileshd@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
institutional ethics committee ,PDEA college of ayurved and research centre, pune |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Known cases of Diabetes mellitus type II or newly diagnosed cases of Diabetes mellitus type II, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Metformin |
Metformin is a known oral hypoglycemic agent of the biguanide class which controls the blood sugar levels.It will be given in a dose of 500mg BD for a period of 90 days. |
Intervention |
Vidangadi ghana vati |
Vidangadi ghana vati contains Vidang(Embelia ribes Burm.f.), Shala (Shorea robusta Gaertn), Arjun (Terminalia arjuna(Roxb.) W. & A), Katphala (Myria esculeuta Buch-Ham), Kadamba Anthocephalus indicus Miq., Lodhra(Symplocos racemosa Roxb.),Asana(Pterocarpus marsupium Roxb.)and Kutaj (Holarrhena antidysenterica(Linn.) Wall.)[is a combination of ayurvedic herbs mentioned in classical text and which is effective in Prameha (diabetes mellitus typeII).It will be given in a dose of 500mg TDS for a period of 90 days. |
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Either a known diabetic on treatment or a newly diagnosed diabetic.
2.Patients presenting classical symptoms of Prameha.
3.Patient with fasting blood sugar up to 250 mg% and post prandial blood sugar up to 500 mg%.
4.Patient showing good, fair and moderate control in HbA1c test.
|
|
ExclusionCriteria |
Details |
1.Patients with fasting blood sugar above 250 mg% and post prandial blood sugar above 500mg%.
2.Insulin Dependent Diabetes Mellitus (IDDM) and those who are under insulin therapy.
3.Pregnant and lactating mothers.
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
|
Permuted block randomization, fixed |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Assesment of symptoms and effest on BSL Fasting and Post prandial, Urine sugar and glycosylated haemoglobin HbA1c
|
90 days (3 months) |
|
Secondary Outcome
|
Outcome |
TimePoints |
Assessment of Lipid profile, Body weight and body mass index. |
90 days (3 months) |
|
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)
|
26/03/2015 |
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
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The syndrome Diabetes Mellitus has largely been covered under the broad heading of Prameha. It is one of the most common metabolic disorder encountered in clinical practice. A number of factors are known to be important for development of Diabetes mellitus, including obesity, excessive caloric diet, and sedentary life style. Two main types of diabetes are Type I and Type II. Now it is no more a disease related to classes but it is also affecting masses. Vidangadi Ghana Vati is a classical formulation mentioned in Bhaishajya Ratnavali that consists of Vidang, Shala, Arjun, Katphala, Kadamba, Lodhra , Asana and Kutaj. Vidanga is of Kashay, Katu rasa and ushna having Ushnaveerya. Shalvruksha has kashayras, rukshaguna and is known pramehaghna. Arjun possesses kashay rasa and is laghuruksha. Katphal is of kashay, tikta, katu rasa and ushna virya having laghuruksha guna. Kadamb which is of madhur, kashayras and Lodhra is kashay and laghu ruksha. Asana which is of Kashay, tikta rasa and laghu ruksha guna and known pamehaghna, and Kutaj which is of Tikta – Kashaya rasa, Laghu ruksha guna causes kaphaghna and kledaghna effects by shoshan karma. Hence this combination possesses properties of a potent medicine useful in Santarpan janya Prameha. To make it suitable and palatable in proposed study ghanavati of Vidangadi Kwatha will be used. Hence this study is designed to evaluate the effect of Vidangadi Ghanavati in Prameha vis a vis Diabetes Mellitus (type II). |