| CTRI Number |
CTRI/2019/05/019355 [Registered on: 24/05/2019] Trial Registered Prospectively |
| Last Modified On: |
19/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trial to assess the safety and efficacy of Gplife Advanced Diabetic Support Tablet as adjuvant therapy in patients with diabetes |
|
Scientific Title of Study
|
Single arm, open label, prospective clinical trial to assess the safety and efficacy of Gplife Advanced Diabetic Support Tablet as adjuvant therapy in patients with diabetes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/19-20/004 Ver. 1.0 dated 18 April 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amar Raykantiwar |
| Designation |
Consultant |
| Affiliation |
Lokmanya Medical Research Centre |
| Address |
OPD 2 Floor 4 314 B Telco Road Chinchwad Pune 411033
Pune
MAHARASHTRA
411033
India |
| Phone |
|
| Fax |
|
| Email |
clinicalresearch.mbg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shridhar Pandya |
| Designation |
R&D- coordinator |
| Affiliation |
Gplife Healthcare Pvt Ltd |
| Address |
708 Infinity tower Near Ayurvedic hospital near railway station
Surat 305003
Pune
MAHARASHTRA
305003
India |
| Phone |
9824917109 |
| Fax |
|
| Email |
gplifehealthcare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shridhar Pandya |
| Designation |
R&D- coordinator |
| Affiliation |
Gplife Healthcare Pvt Ltd |
| Address |
708 Infinity tower Near Ayurvedic hospital near railway station
Surat 305003
Pune
MAHARASHTRA
305003
India |
| Phone |
9824917109 |
| Fax |
|
| Email |
gplifehealthcare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gplife Healthcare Pvt Ltd
708, Infinity tower, Near Ayurvedic hospital, near railway station,
Surat-305003 |
|
|
Primary Sponsor
|
| Name |
Mr Ghanshyam Goti |
| Address |
708, Infinity tower, Near Ayurvedic hospital, near railway station,
Surat-305003
|
| Type of Sponsor |
Other [Director of GP life healthcare Pvt. Ltd.] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhijit Shekhar |
D. Y. Patil College of Ayurved & Research Center |
OPD No. 5
Ground Floor
Vallabh Nagar, Pimpri Pune
Pune
MAHARASHTRA |
9359569457
abhijitshekhar00@gmail.com |
| Dr Amar Raykantiwar |
Lokmanya Medical Research Centre |
OPD 2 Floor 4 Lokmanya Medical Research Center 314/B Telco
Road Chinchwad Pune 411033
Pune
MAHARASHTRA |
8446623333
clinicalresearch@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Dr. D. Y. Patil College of Ayurved and research center |
Approved |
| Lokmanya Medical Research Centre |
Approved |
| Lokmanya Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E139||Other specified diabetes mellituswithout complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gplife-Advance diabetic support |
Subjects will be advised to consume Gplife Advanced diabetic support tablet 2 tablets twice daily, orally 30-45 minutes before meal with water for 2 months. |
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 18-60 (both inclusive) age, both sex.
Patients receiving Oral Hypoglycemic Agents and/or insulin as on-going treatment for diabetes
Haemoglobin A1C (HbA1c) >6.5% and <14.5 % (both inclusive)
Subjects having a body mass index (BMI) of 20 to 35 kg/m2.
Fasting Plasma Glucose (FPG) >120 mg/dL and < 450 mg/dL (both inclusive) |
|
| ExclusionCriteria |
| Details |
•Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT >3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine >1.4 mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
•Women who are pregnant or lactating
• Smokers/Alcoholics and/or drug abusers
•Patients with evidence of malignancy
•Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro- Endocrinal disorders, etc.)
•Involvement in any other study requiring drug therapy
•Renal dysfunction as evidenced by raised serum creatinine from renal function test
•Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg)
•Unwillingness to undergo therapy
•Known hypersensitivity to any of the ingredients of study tablets
•Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess change from Baseline in Fasting Plasma Glucose (FPG).
To assess change from Baseline in 2 Hr. Post Meal Glucose (PMG) to 60 days.
To evaluate change from Baseline in Haemoglobin A1c (HbA1c)
To assess change from Baseline in Fasting Insulin (FI)
To assess change from Baseline in 2 hr. Post Meal Insulin (PMI).
|
Baseline and end of study
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in dose of OHAs
To evaluate changes of [HOMA]-b, insulin resistance (IR) by HOMA-IR
To evaluate C-Peptide level
Evaluation of Urine sugar
Subjective assessment of the clinical symptoms
To evaluate tolerability and safety
To assess change from Baseline in lipid profile to 60 days.
Assessment of vitals during the study period
Global assessment for overall improvement by the subject and investigator
Quality of Life Instrument for Indian Diabetes Patients
|
Baseline and 60 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/05/2019 |
| Date of Study Completion (India) |
03/08/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
03/08/2019 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Diabetes mellitus (DM) is rising in India with more than 62 million diabetic individuals. India (31.7 million) topped world with highest number of people with DM followed by US. Prevalence of DM is predicted to double globally from 171 in 2000 to 366 million in 2030. The prospective clinical trial to assess the safety and efficacy of Gplife Advanced Diabetic Support Tablet as adjuvant therapy in patients with DM is conducted. At two sites, 30 subjects were evaluated till 60 days for Fasting Plasma Glucose (FPG), Post Meal Glucose (PMG) and HbA1c. At initial, mean FPG level was 344.70 ± 80.12 mg/dl, for day 60 it was reduced 155.80 ± 31.44 mg/dl. At baseline visit, the mean PMG level was 436.22 ± 102.73 mg/dl, for day 60 it was reduced to 204.87 ± 27.74 mg/dl and HbA1C % was 10.35 ± 1.95, for day 60 it was reduced to 7.34± 0.97 mg/dl. The reduction in clinical symptoms of patients is also reported. The success of product as an adjuvant therapy can be explained as it caused reduction in doses of insulin and OHA in test population at 60 days. It can be concluded that adjuvant therapy of Gplife Advanced Diabetic Support Tablet significantly effective in reducing levels of fasting plasma glucose (FPG) and Post meal plasma glucose (PMG) from baseline till 60 days. No significant change in any of the safety laboratory parameters and vitals was observed suggesting safety of the Gplife Advanced Diabetic Support Tablet.
|