| CTRI Number |
CTRI/2014/09/005015 [Registered on: 15/09/2014] Trial Registered Prospectively |
| Last Modified On: |
12/08/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial of Lipidil Tablet in comparison with Atorvastatin in patients with abnormal amount of lipids. |
|
Scientific Title of Study
|
A clinical study to evaluate efficacy and safety of ‘Lipidil tablet’ in comparison with ‘Atorvastatin’ in Patients with Dyslipidemia-An Open labeled, Randomized, Single Center, Prospective Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AH/LPDL/01/2014. V0 (11.06.2014) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shrikant Gunvantrao Deshmukh |
| Designation |
Principal and H.O.D. PG Department of Kayachikitsa |
| Affiliation |
Principal, C.S.M.S.S. Ayurveda College Kanchanwadi, Aurangabad |
| Address |
C.S.M.S.S. Ayurveda College Kanchanwadi, Aurangabad
C.S.M.S.S. Ayurveda College Kanchanwadi, Aurangabad
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
9921553999 |
| Fax |
|
| Email |
sgdagd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arjun Kohli |
| Designation |
Director |
| Affiliation |
ARJUN HEALTHCARE |
| Address |
ARJUN HEALTHCARE
11, Krypton towers,
New Prabhadevi Road,
Prabhadevi, Mumbai
11, Krypton towers,
New Prabhadevi Road,
Prabhadevi, Mumbai
Mumbai
MAHARASHTRA
400025
India |
| Phone |
8108829777 |
| Fax |
|
| Email |
arjunhealthcare2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arjun Kohli |
| Designation |
Director |
| Affiliation |
ARJUN HEALTHCARE |
| Address |
ARJUN HEALTHCARE
11, Krypton towers,
New Prabhadevi Road,
Prabhadevi, Mumbai
11, Krypton towers,
New Prabhadevi Road,
Prabhadevi, Mumbai
MAHARASHTRA
400025
India |
| Phone |
8108829777 |
| Fax |
|
| Email |
arjunhealthcare2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Arjun Healthcare 11 Krypton towers New Prabhadevi Road,
Prabhadevi Mumbai
|
|
|
Primary Sponsor
|
| Name |
Arjun Healthcare |
| Address |
11 Krypton towers New Prabhadevi Road, Prabhadevi Mumbai |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| Dr Shrikant Gunvantrao Deshmukh |
OPD of Kayachikitsa |
C.S.M.S.S. Ayurveda College Kanchanwadi, Aurangabad-431005
Aurangabad
MAHARASHTRA |
9921553999
sgdagd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, C.S.M.S.S. Ayurveda College Kanchanwadi, Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Dyslipidemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Atorvastatin 10 mg |
Dosage and Treatment: 1 tablet once daily orally after meals for 3 months. |
| Intervention |
LIPIDIL TABLET |
It contains Guggulu Ext (Commiphora mukul), Methi Ext (Trigonella foenum graecum), Lasun Ext (Allium sativum), Arjun Ext (Terminalia arjuna), Pippali Ext (Piper longum )
Dosage and Treatment: 2 tablets twice daily orally after meals for 3 months.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects diagnosed as Dyslipidemia (LDL-C between 130 and 190 mg/dl, Triglycerides between 150 and 500 mg/dL and TC ≥ 240 mg/dl but not more than 400 mg/dl).
2. Subjects ECG not demonstrating any signs of uncontrolled arrhythmia / acute ischemia.
3. Subjects X- ray chest not showing any active lesion of tuberculosis
4. Female patients must be postmenopausal as defined by no menstruation for at least 12 months, or surgically sterilized for at least three months prior to beginning of the study, or have a negative pregnancy test and agree to avoid pregnancy during the study and one month after the end of the study by using reliable method of contraception.
|
|
| ExclusionCriteria |
| Details |
1. Patients with myocardial infarction, stroke, transient ischemic attack, cardiovascular surgery or major operations within 6 months prior to screening visit.
2. Patients with percutaneous coronary intervention within 3 months.
3. Patients who have taken lipid-lowering medications including statins or any other drug(s) (Ayurveda, Unani, Siddha and Homeopathy) during 4 weeks prior to screening visit.
4. Patients with uncontrolled hypertension at the screening visit. Patients on stable antihypertensive medication may be enrolled provided that the medications and dosage remain stable throughout the study.
5. Patients who are taking anticoagulants except aspirin at < 325 mg/day.
6. Patients with liver dysfunction as indicated by a serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) level of > 1.5-times of upper limit of normal range, or clinical symptoms.
7. Patients with renal dysfunction as indicated by a serum creatinine level above ULN range, or clinical symptoms.
8. Patients with gastric or peptic ulcer within 3 months prior to screening visit.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate efficacy of Lipidil tablet in comparison with Atorvastatin in Patients with Dyslipidemia by assessing Lipid profile
|
Day 0, Day 30, day 60 and day 90.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Cardiac risk bio-markers
2. Tolerability of study drugs by assessing ADRs on study completion.
3. Assessment of Laboratory parameters like Liver function tests (LFT), Renal function tests (RFT), complete blood count (CBC), ESR, Hb%, Urine Examination and ECG
|
Day 0, Day 30, day 60 and day 90.
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
22/09/2014 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NOT YET DONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This
study is an Open labeled, Randomized, Single Center, Prospective clinical study
to evaluate efficacy and safety of ‘Lipidil tablet’ in comparison with
‘Atorvastatin’ in Patients with Dyslipidemia. Tablet Lipidil will be given in a
dose of 2 tablets twice daily orally for 3 months. Atorvastatin 10 mg tablet will
be give once daily orally for 3 months. The trial will be conducted in India. 80
patients (40 patients in each group) will be recruited. The primary outcome
measures will be to evaluate efficacy of Lipidil tablet in comparison with
Atorvastatin in Patients with Dyslipidemia by assessing Lipid profile (Day 0,
Day 30, day 60 and day 90). The secondary objectives will be assessment of Cardiac
risk bio-markers, tolerability of study drugs by assessing ADRs on study
completion and assessment of Laboratory parameters like Liver function tests
(LFT), Renal function tests (RFT), complete blood count (CBC), ESR, Hb%, Urine
Examination and ECG |