| CTRI Number |
CTRI/2009/091/000605 [Registered on: 18/01/2011] |
| Last Modified On: |
15/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A Clinical Study to evaluate the Efficacy and Safety of TLPL/AY/04/2008 as an adjuvant to Oral Hypoglycemic agents (OHAs) in Type 2 Diabetic Patients. |
Scientific Title of Study
Modification(s)
|
A Randomized, Double blind, Placebo controlled, Phase 2 Clinical Study to evaluate the Efficacy and Safety of TLPL/AY/04/2008 as an Add-on therapy with Oral Hypoglycemic agents (OHA) in Type 2 Diabetic Patients. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| TLPL/AY/04/2008/CT-1, Version 2, Dated 24.07.2009 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Dileep Mane |
| Designation |
Chief Physician and Managing Director |
| Affiliation |
Noble Hospital |
| Address |
Noble Hospital 153 Magarpatta City Road Hadapsar Pune
153 Magarpatta City Road Hadapsar
Pune
MAHARASHTRA
411013
India |
| Phone |
9922442350 |
| Fax |
|
| Email |
dileep.mane@yahoo.co.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Dileep Mane |
| Designation |
Chief Physician and Managing Director |
| Affiliation |
Noble Hospital |
| Address |
Noble Hospital 153 Magarpatta City Road Hadapsar Pune
153, Magarpatta City Road, Hadapsar
Pune
MAHARASHTRA
411013
India |
| Phone |
9922442350 |
| Fax |
|
| Email |
dileep.mane@yahoo.co.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Dileep Mane |
| Designation |
Chief Physician and Managing Director |
| Affiliation |
Noble Hospital |
| Address |
Noble Hospital 153 Magarpatta City Road Hadapsar Pune
153, Magarpatta City Road, Hadapsar
Pune
MAHARASHTRA
411013
India |
| Phone |
9922442350 |
| Fax |
|
| Email |
dileep.mane@yahoo.co.in |
|
Source of Monetary or Material Support
Modification(s)
|
| Tulip Lab Private Limited F-20/21 MIDC Ranjangaon Taluka Shirur Dist Pune Pin 412220 |
|
Primary Sponsor
Modification(s)
|
| Name |
Tulip Lab Pvt Ltd |
| Address |
F-20/21 MIDC Ranjangaon Taluka Shirur Dist. Pune Maharashtra State India Pin-412220 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deelip Mane |
Department of Medicine, OPD No. 8, Ground Floor |
Noble Hospital 153 Magarpatta City Road Hadapsar Pune
Pune
MAHARASHTRA |
09922442350
dileep.mane@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Noble Hospital, Hadapsar, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Type II Diabetes mellitus, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo Tablets |
Each film coated tablet contains microcrystalline cellulose, Croscarmellose sodium, Crospovidone, Methyl paraben, Propyl paraben, Colloidal anhydrous silica, Magnesium stearate, Hydroxypropyl methylcellulose, Polyethylene glycol, Talc, Titanium dioxide, Iron oxide red, Iron oxide yellow and Purified water.
Dosage and Duration of Treatment: Two tablets twice daily orally before meals as an add on therapy to oral hypoglycemic agent(s) for three months |
| Intervention |
TLPL/AY/04/2008 |
Each Film coated tablet contains Madhunashini extract (Gymnema sylvestre R.Br), Asana extract (Pterocarpus marcupium Roxb.), Amalaki extract (Emblica officinalis Gaertn), Mamijva extract (Enicostemma littorale Blume) and Jambu extract (Syzygium cumminii Linn)
Dosage and Treatment Duration:
Two tablets twice daily orally before meals as add on therapy to oral hypoglycemic agent(s)for three months |
|
Inclusion Criteria
Modification(s)
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects suffering from type 2 diabetes mellitus for more than one year, and stabilized on mono / polydrug oral anti-diabetic therapy (Sulfonylurea alone or combination of sulfonylurea and Biaguanides) for at least last 3 months.
2. Subjects having HbA1C value between 7-10% (both inclusive) at screening.
3. Subjects having Fasting Plasma Glucose 126-252 mg/dL (both inclusive) at screening.
4. Subjects of male gender or a nonpregnant, nonlactating females, at least six weeks postpartum. A urine pregnancy test is required for all female subjects unless subject has had a hysterectomy, tubal ligation, or is > 2 years postmenopausal.
5. Subjects having a body mass index (BMI) of 20 ? 35 kg/m2.
6. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
|
|
| ExclusionCriteria |
| Details |
1. Subjects on insulin therapy or on oral hypoglycemic agents other than Sulfonylurea and Biaguanides.
2. Subjects suffering from type-1 DM or types of Diabetes mellitus other than Type -2.
3. Subjects having known hepatic or renal disease.
4. Subjects having an active malignancy.
5. Subjects giving history of significant cardiovascular event < 12 weeks prior to randomization.
6. Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds.
7. Subjects having a chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
8. Subjects having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
9. Use of any other investigational drug within 1 month prior to randomization
10. Known hypersensitivity to ingredients used in study drug
11. Pregnant and Lactating females.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
To evaluate the efficacy of TLPL/AY/04/2008 in comparison with matching placebo as add-on therapy to OHA in patients suffering from type 2 Diabetes mellitus by assessing,
1.Changes in Fasting and Postprandial Plasma Glucose levels
2.Changes in HbA1C% Value
|
Day 0, Day 30, Day 60 and Day 90 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1.Changes in fasting Serum insulin level
2.Reduction in dose of OHAs
3.Improvement in clinical symptoms of Type 2 DM
4. Global assessment for overall improvement by the subject
5. Global assessment for overall improvement by the investigator
6. Tolerability of study drugs assessment by study subject and investigator
7. Laboratory parameters like Liver function tests (LFT), renal function tests (RFT), Lipid Profile, Complete blood count (CBC), ESR, Hb% and Urine Examination
|
Day 0, Day 30, Day 60, Day 90 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
26/12/2009 |
| 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
Modification(s)
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Patients of Type-2 DM attending outpatient clinic at Noble Hospital will be screened for eligibility criteria. On screening visit, a written informed consent will be obtained from subjects for their participation in the study. Subject’s history will be recorded and his/her physical examinations will be done. Then patient will undergo investigations (viz. CBC, ESR, Hb%, BSL Fasting and PP,Urine Sugar (Fasting & PP) Serum insulin, HbA1C, Liver function tests, Renal function tests, Lipid profile, Urine routine and microscopic examinations, Urine pregnancy test (only if the subject is female of child bearing potential), Stool routine & microscopic examinations, HIV test, X- ray chest (PA View) and ECG). Diary card to record daily symptoms of diabetes will be provided to patients. A wash out period of 7 days will be advised during which patients will have to refrain from anti-diabetic medicines (Herbal /homeopathic etc) other than OHA prescribed by Investigator. On baseline visit, subject will be recruited in the study if he/she meets all the inclusion criteria. Subjects will then be randomized to one of the two study groups as per the computer generated randomization list. Subjects will undergo general and systemic examinations. At baseline visit and on every follow up visit (except last follow up visit), subjects will be provided with diary card to record daily symptoms of DM. On every follow up visit, filled diary card will be collected and symptoms assessed and graded on clinical symptom scoring scale as given in Appendix-C. At baseline visit and at every follow up visit (except last follow up visit), as per computer generated randomization list, subjects will be provided a HDPE container containing 72 tablets (60 tablets for 15 days + additional 12 tablets for use if the follow up is delayed maximum by three days) of either ?TLPL/AY/04/2008? or matching placebo. Subject will be advised to consume medication in a dose of 2 tablets twice daily orally before meals for next 15 days. Subject will be advised to continue his/her allopathic anti-diabetic medicines (OHAs). Drug compliance will also be assessed by the investigator on every follow up visit. Subjects will be advised to continue the diabetic diet and exercise regimen (which they are already following) during the entire study. Subjects will be called to Noble Hospital for follow up visits on every 15th day upto 90 days after the baseline visit. On every follow up visit, they will undergo general and systemic examinations and assessment of clinical symptoms of type 2 DM will be done. Subject?s blood sugar (fasting & PP) and Urine sugar (Fasting & PP) will be checked on every month. Patient?s global evaluation for overall improvement and Investigator?s global evaluation for overall improvement will be done on completion of the study. Tolerability of the trial drugs will be assessed by the investigator and by the patient at the end of the trial. All the patients will be closely monitored for any Adverse Events starting from baseline visit till the end of the study visit. On final follow up visit (i.e. Day 90) subjects laboratory investigations (viz. CBC, ESR, Hb%, BSL (fasting & PP), Urine Sugar (Fasting & PP), Serum insulin, HbA1C, Liver function tests, Renal function tests, Lipid profile, Urine routine & microscopic, Stool routine & microscopic) will be performed. After completion of 90 days of study treatment, all the subjects will be asked to stop trial medication and take advice of investigator for further treatment. |