| CTRI Number |
CTRI/2022/03/040717 [Registered on: 02/03/2022] Trial Registered Prospectively |
| Last Modified On: |
04/06/2022 |
| 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
|
"To study the effect of Ayurvedic medicine on abnormal lipid profile" |
|
Scientific Title of Study
|
"A Clinical Study of Ayurvedic formulation on Hyperlipidemia" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjiv Kumar |
| Designation |
Assistant Director Ay |
| Affiliation |
CARI under Central Council for Research in Ayurvedic Sciences, New Delhi |
| Address |
Department Technical section Room number 214 Central Ayurveda Research Institute, moti bagh road, Patiala Department Technical section Room number 214 Central Ayurveda Research Institute, moti bagh road, Patiala Patiala PUNJAB 147001 India |
| Phone |
2212393 |
| Fax |
2223663 |
| Email |
drsanjivji@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sanjiv Kumar |
| Designation |
Assistant Director Ay |
| Affiliation |
CARI under Central Council for Research in Ayurvedic Sciences, New Delhi |
| Address |
Department Technical section Room number 214 Central Ayurveda Research Institute, moti bagh road, Patiala Department Technical section Room number 214 Central Ayurveda Research Institute, moti bagh road, Patiala Patiala PUNJAB 147001 India |
| Phone |
2212393 |
| Fax |
2223663 |
| Email |
drsanjivji@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sanjiv Kumar |
| Designation |
Assistant Director Ay |
| Affiliation |
CARI under Central Council for Research in Ayurvedic Sciences, New Delhi |
| Address |
Department Technical section Room number 214 Central Ayurveda Research Institute, moti bagh road, Patiala Department Technical section Room number 214 Central Ayurveda Research Institute, moti bagh road, Patiala Patiala PUNJAB 147001 India |
| Phone |
2212393 |
| Fax |
2223663 |
| Email |
drsanjivji@gmail.com |
|
|
Source of Monetary or Material Support
|
| Desh Bhagat University, Mandi Gobindgarh, Fatehgarh Sahib |
|
|
Primary Sponsor
|
| Name |
Desh Bhagat University |
| Address |
Amloh Road, Mandi Gobindgarh, Fatehgarh Sahib, Punjab |
| Type of Sponsor |
Other [State Private University] |
|
|
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 Sanjiv Kumar |
CENTRAL AYURVEDA RESEARCH INSTITUTE |
Department Technical section Room number 214 Central Ayurveda Research Institute, moti bagh road, Patiala Patiala PUNJAB |
9310133831
drsanjivji@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Central Ayurveda Research Institute, Patiala |
Approved |
| Central Ayurveda Research Institute, Patiala |
Approved |
| Desh Bhagat University, Mandi Gobindgarh, Fatehgarh Sahib |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E889||Metabolic disorder, unspecified. Ayurveda Condition: MEDOROGAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Herb 7 | Capsule of starch powder will be given with the dose of 1gm adhobhakta 2 bd for 84 days | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Herb 7, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 84 Days, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: |
|
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Inclusion Criteria
Modification(s)
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Having all or at least two of the lipids above the normal range as under :
•Serum cholesterol level- ≥200 mg/ dl (≥5.2 mmol/l)
•Serum Triglycerides level-≥150 mg/ dl (≥1.7 mmol/l)
•HDL-C level-˂40 mg/dl (˂1.04 mmol/l)
•LDL- level - ≥130 mg/dl (≥3.4 mmol/l)
Participant willing and able to participate in the study. |
|
| ExclusionCriteria |
| Details |
•Patients with poorly controlled Hypertension (>160/100mmHg)
•Pregnant/ lactating females.
•Patients on prolonged (> 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, immune suppressants, estrogen replacement therapy etc. or any other drugs that may have an influence on the outcome of the study.
•Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.)
•Patients who have a past history of Atrial Fibrillation, or Severe Arrhythmia
•Symptomatic patients with clinical evidence of Heart failure.
•Patients with uncontrolled Diabetes Mellitus (Blood Sugar Fasting > 200mg/dl)
•Patients with concurrent serious hepatic disorder (defined as aspartate amino transferase (AST) and / or alanine amino transferase (ALT), total bilirubin or alkaline phosphatase (ALP) > 3 times upper normal limit) or renal disorders (defined as S.creatinine>1.2mg/dL)
•Patients with uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or Other concurrent severe disease
•Patients with evidence of malignancy
•History of Hypersensitivity to any of the trial drug or its ingredients
•History of Hypothyroidism
•Patients who have completed participation in any other clinical trial during the past six (06) months
•Patients who received any cholesterol lowering medication within last 08 weeks before screening.
•Any other condition which the Investigator thinks may jeopardize the study.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1.Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
2.Percent Change From Baseline in Fasting Serum Cholesterol at Week 12
3.Percent Change From Baseline in Fasting High density lipoprotein (HDL-C) at Week 12
4.Percent Change From Baseline in Fasting Serum Triglycerides (TG) at Week 12
|
84 days |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
i.Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less than or equal to 70 Milligram per Deciliter (mg/dL) at week 12.
ii.Percentage of participants with decrease of Fasting LDL-C of more than 50% from base line at week 12
iii.Percentage of participants with decrease of Fasting Serum cholesterol of more than 50% from base line at week 12
iv.Percentage of participants with decrease of Fasting Serum triglycerides (TG) of more than 50% from base line at week 12
v.Change in body weight and body mass index (BMI) in 12 weeks.
vi.Percentage of participants with increase of fasting High Density lipoprotein Cholesterol (HDL-C) of more than 50% from base line at week 12
|
84 days |
|
Target Sample Size
Modification(s)
|
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 |
Date of First Enrollment (India)
Modification(s)
|
13/06/2022 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The number of obese people in Asia touching epidemic levels costing government millions of dollars in public health care. Now a days due to change in the life style and erratic dietary habits, a major chunk of the populations prefers to take junk food with less nutritive value associated with high risk factors for developing hyperlipidemia. Hyperlipidemia means excess of lipids in the blood. Lipids are not water solube. They float in the blood and can attach themselves to the walls of the arteries causing atherosclerosis. As these atherosclerotic deposits or plaques, grow may sometimes trigger the formation of clots that block the flow of blood. If a clot obstructs one of the narrow coronary arteries it results into myocardial infarction, or heart attack. Hyperlipidemia is associated with increased mortality and predisposes to the development of many diseases like diabetes, hypertension, myocardian infraction, gall bladder disease and certain forms of cancer. It can be viewed as a consequence of the interaction of environmental factors and the individual’s genetic substrate in particular with susceptibility genes. These genes enhance the storage of fat when food is limited and cause increased risk of hyperlipidemia when food is abundant and energy expenditure is reduced. There are a number of appetite suppressing drugs and other formulations in modern medicine but these drugs do not work until and unless they are used continuously. More over some of them are having known side effects. To avoid this, Ayurveda has tried to develop a number of drugs but till today no such combination has been evolved which can cure this disorder. For the management of this disorder a lot of work has been done using a number of herbal drugs. Terminalia Bellerica has reduced the level of lipids in hypercholesterolemic rabbits (1) Garlic was found as lipid lowering agent in a study conducted in Germany on 261 patients (2) Gum guggulu was found effective in estrogen induced hyperlipidemia in chicks (3) In a similar study guggulu has been found effective in lowering serum lipids (4) In another study Albizzia Lebbek saponins have been found to be hypocholesterolemic (5) Amla has been found as hypocholesterolemic agent prevents premature atherosclerosis. Keeping this view in mind present study is aimed to evaluate the clinical effect of Ayurvedic formulation on Hyperlipidemia. Proposed study will be based on clinical study of Ayurvedic formulation which contains multi ingredients. The efficacy of these herbs on hyperlipidemia will be studied. This study will be able to produce an effective low cost and short duration treatment for hyperlipidemia. Due to awareness of patent rules it will be beneficial not to disclose actual formulation of research plan. |