| CTRI Number |
CTRI/2011/09/001996 [Registered on: 09/09/2011] Terminated Trial Registered |
| Last Modified On: |
09/09/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
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Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
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A study to investigate the blood sugar lowering effect of EN-DM-02, EN-DM-04 and EN-DM-05 in comparison with placebo in drug naïve/medication free patients with Type II Diabetes Mellitus under Protocol ID: VL/090707/EN/DM/EN-DM-05. |
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Scientific Title of Study
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An exploratory, randomized, double blind, parallel, placebo controlled study to investigate the blood sugar lowering effect of EN-DM-02, EN-DM-04 and EN-DM-05 in comparison with placebo in drug naïve/medication free patients with Type II Diabetes Mellitus under Protocol ID: VL/090707/EN/DM/EN-DM-05. |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| VL/090707/EN/DM/EN-DM-05 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Aliya Shakeel |
| Designation |
Medical Writer |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
118, Morya House
Off. New Link Road, Andheri (West)
Mumbai
MAHARASHTRA
400053
India |
| Phone |
022-42025703 |
| Fax |
66941179 |
| Email |
medical@vediclifesciences.com |
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Details of Contact Person
Public Query
|
| Name |
Seema Damakale |
| Designation |
Project Manager |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
118, Morya House
118, Morya House
Mumbai
MAHARASHTRA
400053
India |
| Phone |
022-42025711 |
| Fax |
66941179 |
| Email |
seema.d@vediclifesciences.com |
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Source of Monetary or Material Support
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| Exotic Naturals - Sponsor |
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Primary Sponsor
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| Name |
Exotic Naturals |
| Address |
203, Morya Landmark 1,
Off. New Link Road, Andheri (West), Mumbai - 400053 |
| Type of Sponsor |
Research institution |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Anirudh Tripathi |
Life Veda Treatment & Research Centre |
B. P. Road, Next to TV Tower,Worli-400030
Mumbai
MAHARASHTRA |
9820180084
dranirudh_t@yahoo.com, lifeveda@rediffmail.com |
| Dr. Rajesh Kewalramani |
Shop No. 16, Bldg No 13/A |
Shanti Niketan, L. M. Road,Kandar Pada, Dahisar (W)-400068
Mumbai
MAHARASHTRA |
9820024766
rajeshtarna@hotmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee |
Not Applicable |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Drug naïve/medication free patients with Type II Diabetes Mellitus, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
EN-DM-02 |
1 Tablet twice daily for 12 weeks |
| Intervention |
EN-DM-04 |
1 Tablet twice daily for 12 weeks |
| Intervention |
EN-DM-05 |
1 Tablet twice daily for 12 weeks |
| Comparator Agent |
Placebo |
1 Tablet once daily from Day 1 to Day 28. 1 Tablet twice daily from Day 28 to Day 112 |
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Inclusion Criteria
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| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with Type 2 diabetes mellitus, with FBS 150-180 mg/dl and HbA1c of 7% to 8.5 % who are either drug ?naïve or have been medication free for at least 3 months
2) Body Mass Index between 18.5 and 30 kg/m2
Patients willing and able to follow diet and exercise regime for the study duration
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| ExclusionCriteria |
| Details |
1) Patients requiring insulin / having diabetic complications
2) Hypertensive patients with BP ≥ 160/100 mm of Hg
3) Patients on fibrates and niacin (which are known to affect blood sugar levels)
4) Pregnant and nursing women
5) Patients unwilling to practice contraception.
6) Serious hepatic or renal impairment (Liver Dysfunction as evidenced by SGPT level of 1.5 X ULN and Renal Dysfunction as evidenced by Creatinine level of 1.5 X ULN
7) Significant cardiovascular co-morbidities, e.g. symptomatic heart failure, uncontrolled hypertension, history of ischemic heart disease (as evident from ECG), history of stroke and/or Transient Ischemic Attack.
8) Debilitating neurological or psychiatric disorders
9) Known hypersensitivity or allergy to one or more of the herbal ingredients
10) Recent (within last 3 months) participation in a clinical trial.
11) Subjects otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the study
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Method of Generating Random Sequence
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Other |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| To determine if any or all of the Investigational Products (IPs) ? EN-DM-04, EN-DM-02 and EN-DM-05 are significantly better than placebo in reducing fasting blood sugar levels (FBS) as compared to Day 25 in patients with Type II Diabetes mellitus |
Fasting Blood Sugar |
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Secondary Outcome
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| Outcome |
TimePoints |
| To determine if any or all of the Investigational Products (IPs) ? EN-DM-04, EN-DM-02 and EN-DM-05 are significantly better than placebo in reducing HbA1c and FBS as compared to the baseline in patients with Type II Diabetes mellitus
To determine if the combination product EN-DM-05 is more efficacious in lowering HbA1c and /or FBS as compared to EN-DM-02 and EN-DM-04
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Fasting Blood Sugar (FBS)
Glycosylated haemoglobin (HbA1c) |
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Target Sample Size
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Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 1/ Phase 2 |
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Date of First Enrollment (India)
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Date Missing |
| 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 |
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Estimated Duration of Trial
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Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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1) Ingredients of EN-DM-02: Mundi ( Sphaeranthus Indicus) - 450 mg per capsule
2) Ingredients of EN-DM-04: Vijaysar (Pterocarpus marsupium) - 200 mg per capsule
3) Ingredients of EN-DM-05: Mundi (450 mg) + Vijaysar (200 mg) = 650 mg per capsule
This trial was terminated because the Ethics Committee was not satisfied with the study design and refused to give the approval. This trial was terminated before enrolling the subjects.
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