CTRI/2012/07/002776 [Registered on: 06/07/2012] Trial Registered Retrospectively
Last Modified On:
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 formulations in the management of Arthritis.
Scientific Title of Study
Clinical Evaluation of Punarnava Guggulu, Dashmoola ghrita, and Kottamachukadi Tailam in the Management of Osteoarthritis.
Trial Acronym
IMCRP – OA – 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. Ayurveda Central Research Institute (ACRI), New Delhi
2. North Eastern India Ayurveda Research Institute (NEIARI), Guwahati
3. National Research Institute for Panchakarma (NRIP), Cheruthuruthy
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
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 3
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr H Panigrahi
Ayurveda Central Research Institute (ACRI), New Delhi
Ayurveda Central Research Institute, Road No.66, Punjabi Bagh, New Delhi– 110 026 West DELHI
9968074400 011-25225546 drhemanta@sify.com
Dr P K S Nair
National Research Institute for Panchakarma (NRIP), Cheruthuruthy
National Research Institute for Panchakarma, Cheruthuruthy, Via-Shoranur, Distt.-Trichur, Pin-679531 Thrissur KERALA
9446237396 04884-262366 dr_pksnair@yahoo.co.in
Dr T Borah
North Eastern India Ayurveda Research Institute (NEIARI), Guwahati
North Eastern India Ayurveda Research Institute, Borsojai (Bhetapara), Beltola, Guwahati-781028 Kamrup ASSAM
Dose – 10 gm twice daily
Dosage form - Ghrita
Route of Administration – Oral
Time of Administration-Twice a day before food
Anupana-Lukewarm Water
Packing form-300 gm pet jar
Duration of therapy-12 weeks
Intervention
Kottamachukadi Tailam
Dose – 20 ml twice daily
Dosage form - Oil
Route of Administration – Local application
Time of Administration-Twice a day
Packing form-300 ml plastic bottle
Duration of therapy-12 weeks
Comparator Agent
NIL
NIL
Intervention
Punarnava Guggulu
Dose – 1 gm (2 Tablets) twice daily
Dosage form - Tablet of 500 mg
Route of Administration – oral
Time of Administration-Twice a day after food
Anupana-Lukewarm Water
Packing form- Jar containg 60 tablet
Duration of therapy-12 weeks
Inclusion Criteria
Age From
40.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
1. Patients with Primary Osteoarthritis (Diagnosis to be confirmed by Kellgren Lawrence Radiological scale)
2. Pain in the affected joint(s) > six weeks.
3. Willing and able to participate in the study.
ExclusionCriteria
Details
1. History of any surgical /diagnostic intervention with reference to the affected joint(s).
2. Patients who are incapacitated, bedridden or confined to a wheelchair.
3. Patients with co morbidities such as gouty arthritis, rheumatoid arthritis and psoriatic arthritis
4. Patients having any deformity of knee, hip or back.
5. Patients with poorly controlled Hypertension ( >160/100 mm of Hg)
6. Patients with Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr. PP) >200 mg% or HbA1c> 6.5%}.
7. Patients with evidence of malignancy.
8. Patients on prolonged (> 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
9. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
10. Symptomatic patients with clinical evidence of Heart failure.
11. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study.
12. Alcoholics and/or drug abusers.
13. H/o hypersensitivity to any of the trial drugs or their ingredients.
14. Pregnant / lactating woman.
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 WOMAC total score
At Baseline, 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and at the end of follow up after 14 weeks
Secondary Outcome
Outcome
TimePoints
Change in WOMAC stiffness Domain Score
At Baseline, 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and at the end of follow up after 14 weeks
Change in WOMAC Physical function Domain
At Baseline, 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and at the end of follow up after 14 weeks
Change in Patient’s Global Assessment of the Disease Activity Scale
At Baseline, 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and at the end of follow up after 14 weeks
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)
15/06/2011
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 the 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.
Kottamacukkadi Taila is an oil preparation containing Kustha (Saussurea lappa), Sunthi (Zingiber officinale), Vaca (Acorus calamus), Sigru (Moringa oleifera), Lasuna (Allium sativum), Himsra (Capparis spinosa), Devdaru (Cedrus deodara), Sarsapa (Brassica campestris), Rasna (Alpinia galanga), Tila (Sesamum indicum), Dadhi (curd of cow’s milk) and Cinca (Tamarindus indica).
The present study entitled “Clinical Evaluation of Punarnava Guggulu, Dashmoola ghrita, and Kottamacukkadi Taila in the Management of Osteoarthritis†is being undertaken in three peripheral institutes of the CCRAS. The same is in the process of being registered (Reg No. - CTRI/2012/02/002416) 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.