| CTRI Number |
CTRI/2013/01/003308 [Registered on: 21/01/2013] Trial Registered Retrospectively |
| Last Modified On: |
26/08/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A trial to study the efficacy and safety of PDM011011 capsules in comparison with metformin in type 2 diabetic patients. |
|
Scientific Title of Study
|
An Open-Label, Randomized, Active-controlled, Multicentric Study to Assess the Efficacy and Safety of PDM011011 Capsules as Compared to Metformin in Subjects with Type-2 Diabetes Mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PHINGA/0412 Version 1.0, dated 2 April, 2012 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohan Magdum |
| Designation |
Consultant Diabetologist |
| Affiliation |
Visiting Consultant |
| Address |
Ira Clinic, 1205/2, Shivaji Nagar, Shirole Road Opp Sambhaji Park
Pune
MAHARASHTRA
411004
India |
| Phone |
|
| Fax |
|
| Email |
mohanmagdum@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purvi Chawla |
| Designation |
Clinical Leader |
| Affiliation |
Piramal Healthcare Limited |
| Address |
R-Tech Park, 1 A, Nirlon Complex, Off Western Express Highway, Goregaon-(E), Mumbai.
Mumbai
MAHARASHTRA
400 063
India |
| Phone |
|
| Fax |
|
| Email |
purvi.chawla@piramal.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Suthar |
| Designation |
Deputy General Manager - Technocommercial Herbal Operations |
| Affiliation |
Piramal Healthcare Limited |
| Address |
1 A, Nirlon Complex, Off Western Express Highway, Goregaon-(E), Mumbai.
Mumbai
MAHARASHTRA
400 063
India |
| Phone |
02230818210 |
| Fax |
|
| Email |
ashish.suthar@piramal.com |
|
|
Source of Monetary or Material Support
|
| Piramal Healthcare Limited |
|
|
Primary Sponsor
|
| Name |
Piramal Healthcare Limited |
| Address |
R-Tech Office, 1 Nirlon Complex, Off Western Express Highway, Goregaon - (E), Mumbai - 400 063. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shrikant V Deshpande |
Ashirwad Hospital and Medical Research Centre |
Sec 32 Maratha Section Near Jijamata Udyan Ulhasnagar
Thane
MAHARASHTRA |
00919822017445
shrikantvdeshpande@rediffmail.com |
| Dr Snehal Tanna |
Clinic De Care |
A207 Nagesh Tower Hariniwas Circle
Thane
MAHARASHTRA |
00919821375727
clinicdecare@doctor.com |
| Dr Atul Deshpande |
Ethika Clinical Research Center |
Siddheshwar Arcade B Wing 1st floor Gate no 1 Kalwa
Thane
MAHARASHTRA |
00919821183445
atuldeshpande1104@yahoo.com |
| Dr Mohan Magdum |
Ira Clinic |
1205/2 Shivaji Nagar Shirole Road Off Sambhaji Park
Pune
MAHARASHTRA |
00919822217243
mohanmagdum@gmail.com |
| Dr Sharat Kolke |
Kolkes Clinic |
A-1 Nightingale Ground Floor LBS Marg Kamani Kurla (W)
Mumbai
MAHARASHTRA |
00919820059062
sharatkolke@hotmail.com |
| Dr Shailaja Kale |
Orange Diabetes Clinical Research Unit |
Adwait Apartment Vasant Baug Society Bhiwewadi
Pune
MAHARASHTRA |
00919822055458
drshailaja@yahoo.com |
| Dr Yogesh Kadam |
Poona Diabetes Centre |
Office No 8 1st floor Bharat Arcade 2394 A East Street Opp Burger King Poolgate
Pune
MAHARASHTRA |
0919823141402
poonadiabetescentre@gmail.com |
| Dr Aniruddha Tongaonkar |
Tongaonkar Hospital |
Plot no 17 S No 47 Opposite Bajaj Auto Vivek Nagar Akurdi
Pune
MAHARASHTRA |
00919822050947
aniruddha_tongaonkar@yahoo.com |
| Dr Vikas Pai |
Vikas Govind Pai Clinical Research Foundation |
778/B1 Abhinav Apartments Next to Congress House Shivaji Nagar
Pune
MAHARASHTRA |
00919890035437
paivikas@indiatimes.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Mumbai_AshirwadHospitalMedicalResearchCentre_Clinical Ethics Forum_Dr_ShrikantDeshpande |
Approved |
| Mumbai_ClinicdeCare_ClinicalEthicsForum_Dr_SnehalTanna |
Approved |
| Mumbai_EthikaClinicalResearchCentre_Clinical Ethics Forum_Dr_AtulDeshpande |
Approved |
| Mumbai_Kolkes Clinic_Clinical Ethics Forum_Dr_Sharat Kolke |
Approved |
| Pune_Ira Clinic_Axiom Life sciences Independent Ethics Committee_Dr_MMagdum |
Approved |
| Pune_OrangeDiabetesSpecialityClinic_Axiom Life Sciences Independent Ethics Committee_Dr_ShailajaKale |
Approved |
| Pune_PoonaDiabetesCentre_Axiom Life Sciences Independent Ethics Committee_Dr_YogeshKadam |
Approved |
| Pune_TongaonkarHospital_Axiom Life Sciences Independent Ethics Committee_Dr_AnirudhaTongaonkar |
Approved |
| Pune_VikasPaiClinicalResearchFoundation_MahalasaIndependentEthicsCommittee_Dr_VikasPai |
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 |
Metformin tablets |
Contains 500 mg metformin tablet. The dose of metformin is 1500 mg per day and is administered as 1 tablet during or after breakfast, lunch and dinner. It is administered orally for a period of 15 weeks. |
| Intervention |
PDM011011 (Bitter melon capsules) |
Capsule contains 400 mg extract of standardized powder of bitter melon juice.
The dose is 1200 mg per day and is administered as 1 capsule before breakfast and 2 capsules before dinner. Also it is administered orally for a period of 15 weeks. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 diabetic patients with an HbA1c between 7 to 10% and fasting plasma glucose between 110 mg/dl and 250 mg/dl. |
|
| ExclusionCriteria |
| Details |
Patients of type 1 diabetes, secondary diabetes mellitus, pregnany or lactating women, with any other clinically significant abnormalities. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in fasting plasma glucose between active and comparator groups |
Baseline and week 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in HbA1c between active and comparator groups |
Baseline and week 15 |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/08/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Diabetes management primarily involves diet and lifestyle modifications followed by treatment with oral agents. Treatment with diet, insulin and oral agents like sulfonylurea, or metformin is known to improve glycemia. The main constituent of PDM011011 is a powder of the natural juice of Karela or bitter melon. Karela is an edible vegetable item in Indian food and has been known for his blood sugar lowering as well as lipid lowering capabilities. Several studies and anecdotal evidence show that bitter melon capsules are associated with improved glycemic control, lower post-prandial sugar levels and triglyceride levels, which help in decreasing the risk for coronary heart diseases.
Based on promising response in previous user trials and innovation in the extraction process, PHL proposed a comparative trial to evaluate the efficacy and safety of bitter melon capsule versus metformin, which is the standard of choice in patients of type 2 diabetes mellitus.
This is the first human trial with this product and hence, no prior clinical data is available.
|