| CTRI Number |
CTRI/2019/07/020229 [Registered on: 17/07/2019] Trial Registered Prospectively |
| Last Modified On: |
15/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study on AYRL Capsule in patients with elevated cholesterol level |
|
Scientific Title of Study
|
An Open Label, Randomized, Comparative (active), Multi-center, prospective clinical study to evaluate Efficacy and Safety of AYRL Capsule in patients suffering from Dyslipidemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AYRL/DYSLPD/WLX/2019, Version 1.0, 12th Jun 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prasanna Mogasale |
| Designation |
Professor |
| Affiliation |
S.D.M. College of Ayurveda, Kuthpady,Udupi |
| Address |
P.G.Department of Kayachikitsa and Manasaroga
Ground Floor, OPD No. 7
S.D.M. College of Ayurveda, Kuthpady,Udupi,Karnataka
Udupi
KARNATAKA
574118
India |
| Phone |
9483052395 |
| Fax |
|
| Email |
pnmogasale73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Welex Laboratories Pvt. Ltd.
1002, Marathon Innova Nextgen,
Off Ganpatrao kadam marg,
Lower Parel, Mumbai -400013 |
|
|
Primary Sponsor
|
| Name |
Welex Laboratories Pvt Ltd |
| Address |
1002, Marathon Innova Nextgen, Off Ganpatrao kadam marg, Lower Parel, Mumbai -400013 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shishr Pande |
Ayurved Seva Sanghs Ayurved Mahavidyalaya |
OPD No 7A, Ground Floor,
Ayurved Sanshodhan Vibhag, Ayurved Seva Sanghs Ayurved Mahavidyalaya, Ganeshwadi, Panchvati, Nashik – 422003
Nashik
MAHARASHTRA |
9420830818
shishir.nsk@gmail.com |
| Dr Prasanna Mogasale |
S.D.M. College of Ayurveda |
OPD No. 7, Ground Floor, P.G.Department of Kayachikitsa and Manasaroga, S.D.M. College of Ayurveda, Kuthpady Udupi Karnataka 574 118
Udupi
KARNATAKA |
9483052395
pnmogasale73@gmail.com |
| Dr Vyankatesh K Shivane |
Sadhana Diabesity Clinic |
OPD Department,
Room No.1, B-6 New
Bhavana Building, SVS
Rd, Above Rajashree
Productions &
Marshalls Showroom,
Prabhadevi, Mumbai-400025
Mumbai
MAHARASHTRA |
9820084780
drvkshivane@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Clearance committee –Human, Sri Dharmasthala Manjunatheshwara College of Ayurveda, Laxminarayana Nagar,P.O.Kuthpady,Dist-Udupi |
Approved |
| Institutional Ethics Committee, Ayurved seva sangh Ayurved Mahavidyalaya, Nashik |
Approved |
| Inter System Biomedica Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Atorvastatin 10 mg |
Dosage and Treatment Duration: One tablet of Atorvastatin 10 mg daily orally after meals with water for 90 days |
| Intervention |
AYRL Capsule |
AYRL Capsule contains Commiphora mukul, Terminalia arjuna, Andrographis paniculata Bergenia ligulata, Zingiber officinale, Crataeva nurvala, Piper longum
Dosage and Treatment Duration: 2 Capsules twice daily orally after meal with lukewarm water for 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects diagnosed of Dyslipidemia (LDL-C between 130 and 190 mg/dl or Triglycerides between 150 and 500 mg/dL or TC ≥ 240 mg/dl but not more than 400 mg/dl) who are not taking any Hypo-lipidemic agents including Statins
2.Subject’s ECG not demonstrating any signs of uncontrolled arrhythmia / acute ischemia.
3.A urine pregnancy test will be required for all female subjects unless subject has had a hysterectomy, tubal ligation, or is > 2 years post menopause.
4.Female subjects who agree to avoid pregnancy during the study and one month after the end of the study by using reliable method of contraception.
5.Subjects willing to follow the procedures as per the study protocol and voluntarily signing informed consent form. |
|
| ExclusionCriteria |
| Details |
1.Subjects with myocardial infarction, stroke, transient ischemic attack, cardiovascular surgery or major operations or any significant cardiovascular event within 6 months prior to screening visit.
2.Subjects with history of gastric or peptic ulcer within 3 months prior to screening visit.
3.Subjects with uncontrolled diabetes mellitus and uncontrolled hypertension
4.Subjects with medical history of pancreatitis, cholestasis, nephrotic syndrome, gall bladder disease, or primary biliary cirrhosis within last six months.
5.Subjects of Hypothyrodism with TSH levels of >10mg% will be excluded
6.Subjects 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.Subjects with clinical significant renal dysfunction as per investigator’s opinion
8.Subjects having an active malignancy and tuberculosis.
9.Subjects with history of chronic, contagious infectious disease, such as active tuberculosis or Hepatitis B or C or HIV.
10.Use of any other investigational drug within 1 month prior to randomization
11.Known hypersensitivity to ingredients used in study drugs
12.Pregnant and Lactating females.
13.Any other condition, which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Comparative change in Low density Lipoprotein (LDL) levels after three months of treatment between the groups
2.Comparative change in Serum Triglycerides and Total Cholesterol levels after 90 days of treatment between the groups
|
Day -7, Day 45, Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Comparative changes in HDL, VLDL, TC/ HDL ratio, LDL/HDL ratio between the groups
2.Changes in Cardiac biomarkers between the groups
3.Monthly changes in weight, BMI, waist circumference, Hip Circumference, waist: Hip ratio in the two groups.
4.Monthly changes in BMR, Body fat percentage, total body water, LBM between the groups
5.Global assessment for overall change by the investigator and subject
6.Change in Laboratory parameters, vitals and ADRs and ECG |
Day -7, Day 45, Day 90 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
19/07/2019 |
| 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
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet Done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is an open label, randomized, comparative (active), multi-center,
prospective study to evaluate
efficacy and safety of AYRL Capsule in patients suffering from
Dyslipidemia. The study will be
conducted at two sites in India. As per computer generated randomization list,
subjects will be randomized to either of the two groups i.e. AYRL Capsules (2 capsules twice a day) or Atorvastatin
(10 mg once a daily) for 90 days. The primary objectives of the study will be to
compare change in LDL levels over three months of the
study treatment between the groups and to compare change in serum triglycerides and total Cholesterol levels between the groups. The secondary objectives of the study will be to compare
monthly changes in Serum High density lipoprotein (HDL), Very low
density lipoprotein (VLDL), TC/ HDL ratio, LDL/HDL ratio over three months of study
treatment between the groups, changes in Cardiac
biomarkers [Hs-CRP, Homocysteine, Lipoprotein (a), ApolipoproteinA1 (Apo A1),
Apolipoprotein B (Apo B), Apo B / Apo A1 ratio] after 90 days of treatment
between the groups, to compare monthly changes in weight, BMI,
waist circumference, Hip Circumference, waist: Hip ratio Basal Metabolic Rate
(BMR), Body fat percentage (Instrumental evaluation), total body water, lean
body mass (LBM), Neck circumference, Upper mid arm circumference, calf
circumference between the groups, to assess overall change by investigator and by subject between the
groups and to assess tolerability of study treatments by assessing ADRs, vitals and
assessment of safety laboratory investigations. |