| CTRI Number |
CTRI/2012/05/002661 [Registered on: 18/05/2012] Trial Registered Retrospectively |
| Last Modified On: |
08/05/2012 |
| Post Graduate Thesis |
Yes |
| 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 Rheumatoid Arthritis. |
|
Scientific Title of Study
|
Clinical Evaluation of Simhanaada Guggulu and Brihata Saindhavadi Taila in the Management of Rheumatoid Arthritis. |
| Trial Acronym |
ACT- RA-2010 |
|
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 (co-ordinator ACT project) |
| 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 (co-ordinator ACT project) |
| 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
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 (co-ordinator ACT project) |
| 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
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. Institute of Post-Graduate Training & Research in Ayurveda (IPGT&RA), Jamnagar.
2. Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda, Udupi.
3. Government Ayurveda College, Thiruvananthapuram |
|
|
Primary Sponsor
|
| Name |
Department of AYUSH Ministry of Health Family Welfare Government of India |
| Address |
Department of AYUSH, Ministry of Health & Family Welfare,
Government of India, IRCS Building, Red Cross Road, New
Delhi-110001 |
| Type of Sponsor |
Government funding agency |
|
|
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 G Vinodkumar Dr Aji K S |
Government Ayurveda College, Thiruvananthapuram |
Department of Panchakarma, Thiruvananthapuram-695001
Thiruvananthapuram
KERALA |
9446417288
0471-2473656
drgvinodkumar@yahoo.com |
| Dr A R Dave Dr Pravin Kharadi |
Institute of Post-Graduate Training & Research in Ayurveda (IPGT&RA), Jamnagar |
Department of Kayachikitsa, Gujarat Ayurved University,Jamnagar-361001
Jamnagar
GUJARAT |
9824171817
288-2676856
alankruta@yahoo.com |
| DrNiranjan Rao DrVishwanath Wasedar |
Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda, Udupi |
Department of Panchakarma, P.O. – Kuthpady, Laxminarayana Nagara, Udupi-574118
Udupi
KARNATAKA |
9448835203
0820-2533970
niranjanrao_a@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Govt. Ayurveda College, Thiruvananthapuram, Kerala, India |
Approved |
| Institutional Ethics Committee, IPGT&RA, Jamnagar, Gujarat, India |
Approved |
| Institutional Ethics Committee, SDM College of Ayurveda, Udupi, Karnataka, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Rheumatoid Arthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Simhanaada Guggulu and Brihata Saindhavadi Taila |
SIMHANAADA 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 after food;
Anupana-Lukewarm Water;
Packing form- Bottle containg 60 tablets;Duration of therapy-12 weeks; And BRIHATA SAINDHAVADI TAILA: 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. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of either sex with age between 20 and 60 years
2) Presence of any four out of the following seven criteria (according to 1987, revised criteria of American College of Rheumatology)
a. Morning stiffness: Stiffness in and around joints lasting one hour before maximal improvement (More than 6 week’s duration).
b. Arthritis of three or more joints, at least three joint area, observed by Physician, having pain with soft tissue swelling or joint effusion, not just bony over growth, (more than 6 weeks duration).
c. Arthritis of hand joints, at least 1 area in wrist and hand is swollen (more than 6 weeks duration).
d. Symmetric arthritis (more than 6 week’s duration).
e. Presence of rheumatoid Nodules
f. Serum rheumatoid factor- positive
g. Typical radiographic changes of arthritis on PA view of hand & wrist radiograph that must include erosions or unequivocal bony decalcification, localized in or adjacent to involved joints.
3) PATIENTS Willing and able to participate in the study for 16 weeks. |
|
| ExclusionCriteria |
| Details |
1. Patients who have developed complications of Rheumatoid Arthritis e.g. deformity of joints / bones , pleura-pericardial disease, or else.
2. Patients who are unable to walk without support and / or confined to wheel chair.
3. Patients with structural deformity as the complication of RA.
4. Patients with poorly controlled Hypertension ( >160/100 mm of Hg)
5. Patients with Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr. PP)
>200 mg% OR HbA1c> 6.5%}
6. Patients diagnosed with other arthritis like gouty arthritis, tuberculous arthritis etc.
7. Patients on prolonged (> 6 weeks) medication with corticosteoids, antidepressants,
anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
8. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome,
Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
9. Symptomatic patients with clinical evidence of Heart failure.
10. 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.
11. Alcoholics and/or drug abusers.
12. H/o hypersensitivity to any of the trial drugs or their ingredients.
13. Pregnant / lactating woman.
14. Patients who have completed participation in any other clinical trial during
the past six (06) months.
15. 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 |
| • Changes in DAS-28 score |
At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Change in Disability Index (The Indian Health Assessment Questionnaire)
• Change in acute phase reactants – ESR and CRP
• Change in Health Questionnaire SF-36 |
At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week.
SF-36 is assessed at Baseline, 84th day and at the end of follow up after 16 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)
|
10/01/2011 |
| 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="6"
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
|
Aimed at scientific validation of the clinical efficacy and safety of twenty nine (29) classical Ayurvedic pharmacopoeial formulations, multicentre clinical trials have been initiated as an activity under the Ayurveda Clinical Trials (ACT) project of the Ayurvedic Pharmacopoeia Committee (APC) during August 2010 in eighteen (18) disease conditions involving fifty four (54) M.D/PhD (Ay.) research scholars in eight (08) postgraduate Ayurveda colleges across the country. Simhanaada Guggulu is a polyherbal Ayurvedic formulation containing Haritaki (Terminalia chebula), Bibhitaka (Terminalia belerica), Amlaki (Emblica officinalis), Gandhaka (Sulphur), Guggulu (Commiphora wightii) and Eranda (Ricinus communis). Brihata Saindhavadi Taila is a medicated classical Ayurvedic oil preparation contain Saindhava lavana (Rock salt), Gajapippali (Scindapsus officinalis), Rasana (Alpinia galanga), Satpuspa (Anethum sowa), Yavani (Trachyspermum ammi), Svarjiksara (Crude alkaline earth), Marica (Piper nigrum), Kustha (Saussurea lappa), Sunthi (Zingiber officinale), Saurvancala Lavana (Black salt), Vida Lavana, Vaca (Acorus calamus), Ajmoda (Apium leptophyllum), Yashtimadhu (Glycyrrhiza glabra), Sveta Jiraka (Cuminum cyminum), Puskara (Inula racemosa), Pippali (Piper longum), Eranda Taila (Ricinus communis), Satapuspajambu (Anethum sowa), Kanjika (Sour gruel) and Mastu (Curd whey from cow milk). The present study is being undertaken in three post graduate Ayurveda colleges involving the post graduate scholars who are doing the clinical trials to scientifically study and validate the clinical efficacy and safety of Simhanaada Guggulu and Brihata Saindhavadi Taila- classical Ayurvedic formulation which have been in use since ages and found to be useful in treating Rheumatoid Arthritis and promoting the health. The Central Council for Research in Ayurvedic Sciences (CCRAS) is the nodal organization to co-ordinate and monitor these trials. CCRAS has provided the necessary infrastructure to the participating colleges, technical inputs (including the clinical trial protocols), trial drugs and training to the researchers involved in the project. |