| CTRI Number |
CTRI/2012/03/002528 [Registered on: 28/03/2012] Trial Registered Retrospectively |
| Last Modified On: |
23/03/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to see the effect of some Ayurvedic formulation in the management of Lipid Disorders. |
|
Scientific Title of Study
|
Clinical Evaluation of Vyoshadi Guggulu and Haritaki Churna in the Management of Dyslipidemia. |
| Trial Acronym |
IMCRP – DLD – 2010 - 2011 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep Dua |
| Designation |
Research Officer (Project co-ordinator) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri
West
DELHI
110058
India |
| Phone |
011-28525831 |
| Fax |
011-28520748 |
| Email |
duadrpradeep@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Dua |
| Designation |
Research Officer (Project co-ordinator) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri
West
DELHI
110058
India |
| Phone |
011-28525831 |
| Fax |
011-28520748 |
| Email |
duadrpradeep@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Dua |
| Designation |
Research Officer (Project co-ordinator) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri
West
DELHI
110058
India |
| Phone |
011-28525831 |
| Fax |
011-28520748 |
| Email |
duadrpradeep@gmail.com |
|
|
Source of Monetary or Material Support
|
| Support in terms of infrastructural facilities:
1. National Research Institute for Panchakarma (NRIP), Cheruthuruthy
2. National Institute of Ayurveda Pharmaceutical Research (NIAPR), Patiala.
3. National Ayurveda Research Institute for Vector Borne Diseases (NARIVBD), Vijayawada |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences CCRAS |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri, New Delhi-110058, INDIA |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr V Subhose |
National Ayurveda Research Institute for Vector Borne Diseases (NARIVBD), Vijayawada |
National Ayurveda Research Institute for Vector Borne Diseases,
Indira Gandhi Municipal Stadium Complex A,
First Floor, North Wing
Vijayawada-520010
Krishna
ANDHRA PRADESH |
9490424439
0175-2228361
dr_vsubhose@yahoo.com |
| Dr M M Rao |
National Institute of Ayurveda Pharmaceutical Research (NIAPR), Patiala |
National Institute of Ayurveda Pharmaceutical Research (NIAPR),
Moti Bagh Road, Patiala-147001
Patiala
PUNJAB |
9501696925
0175-2228361
meda_mrao@yahoo.co.in |
| Dr P Radhakrishnan |
National Research Institute for Panchakarma (NRIP), Cheruthuruthy |
National Research Institute for Panchakarma
Cheruthuruthy-679531
Thrissur
KERALA |
9495076710
04884-262366
dr_radhakrishnan46@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, NIAPR, Patiala, Punjab. |
Approved |
| Institutional Ethics Committee, NARIVBD, Vijayawada. |
Approved |
| Institutional Ethics Committee, NRIP, Cheruthuruthy. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Dyslipidemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Vyoshadi Guggulu along with Haritaki Churna |
VYOSHADI GUGGULU-Dose – 1.5 gm (3 Tablets) twice daily;
Dosage form - Tablet of 500 mg
Route of Administration – oral
Time of Administration-Twice a day before food
Anupana-Lukewarm Water
Packing form- Bottle containg 60 tablets
Duration of therapy-12 weeks AND HARITAKI CHURNA-Dose – 3 gm twice daily; Dosage form – Sachet of 3 gm each Route of Administration – Oral Time of Administration-Twice a day before food Anupana-Lukewarm Water Packing form-Plastic jar of 90 grams containing 30 sachets Duration of therapy-12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having
LDLc 100mg/dL - 160mg/dL and / or
Serum cholesterol 200mg/dL - 250mg/dL and / or
Serum Triglycerides –150mg/dL - 250 mg/dL
2. Willing and able to participate in the study for 16 weeks |
|
| ExclusionCriteria |
| Details |
1. Patients who have received any cholesterol lowering medication (Modern Drug) within last 8 weeks.
2. Patients having Type III and Type IV hypercholesterolaemia
3. Patients with poorly controlled Hypertension (> 160 / 100 mm Hg)
4. Patients with evidence of malignancy
5. Patients on prolonged (> 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, immunosuppressants, estrogen replacement therapy etc. or any other drugs that may have an influence on the outcome of the study.
6. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.)
7. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
8. Symptomatic patient with clinical evidence of Heart failure.
9. Patients having uncontrolled Diabetes Mellitus i.e.HbA1c > 10%
10. Patients with concurrent serious hepatic disorder (defined as aspartate aminotransferase (AST) and / or alanine aminotransferase (ALT), total bilirubin or alkaline phosphatase (ALP) > 2 times upper normal limit) or renal disorders (defined as S.creatinine >1.2mg/dL), severe pulmonary dysfunction (uncontrolled asthma and chronic obstructive pulmonary disease [COPD]), inflammatory bowel disease or any other condition that may jeopardize the study..
11. Pregnant/ lactating females.
12. Patients on oral contraceptives.
13. Alcoholics and/or drug abusers.
14. H/o hypersensitivity to any of the trial drugs or their ingredients.
15. Patients who have completed participation in any other clinical trial during the past six (06) months.
16. Any other condition which the Principal Investigator thinks may jeopardize the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Lipid Profile |
At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 14th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in the Quality of Life (SF-36 Health Survey) Score |
At Baseline, 84th day and at the end of follow up after 14th week |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 2 |
|
Date of First Enrollment (India)
|
03/08/2011 |
| 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) |
Open to Recruitment |
|
Publication Details
|
To be published after completion of the clinical trials in all the three centers. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The Central Council for Research in Ayurvedic Sciences (CCRAS) is an autonomous body under the Department of AYUSH (Ayurveda, Yoga &Naturopathy, Unani, Siddha and Homeopathy), Ministry of Health & Family Welfare, Government of India. CCRAS is an apex body in India for the formulation, co-ordination, development and promotion of research on scientific lines in the Ayurveda system of medicine. Aimed at generating evidence for the scientific validation of the clinical efficacy and safety of twenty five classical Ayurvedic formulations, multicentre clinical trials have been initiated in sixteen disease areas across nineteen peripheral institutes of the Council as an activity under the Intra Mural Clinical Research (IMR) program. This initiative is basically a supplement to the similar venture being worked out as an activity under the Ayurveda Clinical Trials (A.C.T.) project of the Ayurvedic Pharmacopoeia Committee (APC) wherein, clinical trials on eighteen disease conditions are underway in eight post graduate Ayurveda colleges across the country. Vyoshadi Guggulu is a poly herbal preparation containing Sunthi (Zingiber officinale), Marica (Piper nigrum), Pippali (Piper longum), Citraka (Plumbago zeylanica), Musta (Cyperus rotundus), Haritaki (Terminalia chebula), Bibhitaka (Terminalia belerica), Amlaki (Emblica officinalis), Vidanga (Embelia ribes) and Guggulu (Commiphora wightii). Haritaki Churna consists of dried pericarp of mature fruits of Harada (Terminalia chebula). The present study entitled “Clinical Evaluation of Vyoshadi Guggulu and Haritaki Churna in the Management of Dyslipidemia†is being undertaken in three peripheral institutes of the CCRAS. A similar study has been registered (Reg No CTRI/2012/01/002374) in the Clinical Trials Registry, India (CTRI) as an activity under the ACT project. The cumulative evidence generated as an activity under the ACT project as well as IMR programme is expected to scientifically substantiate the claims regarding clinical efficacy and safety of these classical Ayurvedic formulations. |