| CTRI Number |
CTRI/2017/03/008057 [Registered on: 09/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
21/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical study of DIADROPSZ, an ayurvedic product in treatment of Type 2 Diabetes Melitus |
|
Scientific Title of Study
|
A Single Centre Pilot Open Label Clinical Trial to assess the Safety and Efficacy of Diadropsz Arka as a Monotherapy and as an Adjuvant in Patients with Type 2 Diabetes Mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CLIN-PUN-VR-01 Version 01 Dated 11 May 2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sarat K Babu |
| Designation |
Principal Investigator |
| Affiliation |
Nangelil Ayurveda Medical College |
| Address |
Associate Professor
Room No 2
Dept of Roga Nidana
Nangelil Ayurveda Medical College
Nellikuzhi
Kothamangalam
Ernakulam, Kerala
Ernakulam
KERALA
686691
India |
| Phone |
09446413215 |
| Fax |
|
| Email |
saratayur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreejith Sreekumar |
| Designation |
Chief Executive Officer |
| Affiliation |
Clinfound Clinical Research Services Pvt Ltd |
| Address |
Clinfound Clinical Research Services Pvt. Ltd
Chennal Buildings
Kumaramangalam P O
Thodupuzha,
Kerala
Idukki
KERALA
685597
India |
| Phone |
09995342978 |
| Fax |
|
| Email |
drsreejith@clinfound.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sreejith Sreekumar |
| Designation |
Chief Executive Officer |
| Affiliation |
Clinfound Clinical Research Services Pvt Ltd |
| Address |
Clinfound Clinical Research Services Pvt. Ltd
Chennal Buildings,
Kumaramangalam P O
Thodupuzha,
Kerala
Idukki
KERALA
685597
India |
| Phone |
9995342978 |
| Fax |
|
| Email |
drsreejith@clinfound.com |
|
|
Source of Monetary or Material Support
|
| Punarjanis Lifesciences No.13 ICC, 1st Avenue, B Sector,6th Street, Near Andaman and Nicobar Administration Office, Anna Nagar West Extension, Chennai, Tamil Nadu 600101 |
|
|
Primary Sponsor
|
| Name |
Clinfound Clinical Research Services PvtLtd |
| Address |
Chennal Buildings, Kumaramangalam PO, Thodupuzha,Idukki,Kerala - 685597 |
| Type of Sponsor |
Contract research organization |
|
|
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 |
| DrSarat K Babu |
Nangelil Ayurveda Medical College |
Room No 2
Department of Roga Nidana
Nellikuzhi
Kothamangalam
Ernakulam, Kerala 686691
Ernakulam
KERALA |
09446413215
saratayur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Society For Medical and Healthcare Research Independent Ethics Committee,Cochin,Kerala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Patients with Type 2 Diabetes Melitus who are drug naive and on adjuant medication, (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DiaDropsz Arka alone |
30 drops thrice daily after food for 3 months.DiaDropsz is an arka proparation |
| Comparator Agent |
Oral Hypoglycemic Agent with DiaDropsz Arka |
DiaDropsz arka 30 drops TID after food for 3 months. OHA dose will be the same as that at baseline |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Body mass index (BMI) below 40 kg/m².
Group A
1.25 Drug naive or previously treated Type 2 DM or patients willing to shift to sole Ayurvedic treatment.
2.Hemoglobin A1c (HbA1c) ≥7.5% and ≤11% or
3.Fasting Plasma Glucose (FPG) ≥130 mg/dL
Group B.
1.25 patients with Type 2 DM with Modern Pharmaceutical Medication having insufficient glucose control.
2.Insufficient glucose control defined as laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) ≥7.5% and ≤11% or a Fasting Plasma Glucose (FPG) ≥130 mg/dL
|
|
| ExclusionCriteria |
| Details |
1.Type 1 diabetes.
2.Current need for Insulin treatment.
3.Complication of DM.
4.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 > 1.6mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
5.Women who are pregnant or lactating
6.Smokers/Alcoholics and/or drug abusers
7. Patient with poorly controlled Hypertension
8. Patients with evidence of malignancy
9. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from Baseline in Hemoglobin A1c (HbA1c) at Week 12 (End of study). |
Baseline and Week 12 (End of study). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from Baseline in Fasting Plasma Glucose (FPG) |
Baseline Day 10 Day 20 Day 30
Day 40 Day 50 Day 60 Day 70 Day 80 Day 90(End of Study) |
| Change from Baseline in 2-hr Post-Meal Glucose (PMG) |
Baseline Day 10 Day 20 Day 30
Day 40 Day 50 Day 60 Day 70 Day 80 Day 90(End of Study) |
| Changes from Baseline in BMI |
Baseline Day 10 Day 20 Day 30
Day 40 Day 50 Day 60 Day 70 Day 80 Day 90(End of Study |
| Symptomatic changes assessed using Ayurvedic symptom questionnaire |
Baseline Day 10 Day 20 Day 30
Day 40 Day 50 Day 60 Day 70 Day 80 Day 90(End of Study) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/09/2016 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
The study will be duly published in indexed journals |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Most of the other
treatment methods for diabetes mellitus regard it as a largely dietary disease.
But Ayurveda here differs widely in its outlook. Ayurveda does not regard
diabetes mellitus as a disease that can be treated by mere medicine or by a
dietary regimen. The Ayurvedic treatment for diabetes mellitus is based on an
entire change in the lifestyle of the person.The current study looks at the efficacy of an Ayurveda combination in Diabetes Melittus.
|