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CTRI Number  CTRI/2014/12/005242 [Registered on: 02/12/2014] Trial Registered Prospectively
Last Modified On: 16/01/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   STUDY OF SOME AYURVEDIC MEDICINES IN THE TREATMENT OF AMAVATA- A JOINT DISEASE 
Scientific Title of Study   CLINICAL EVALUATION OF VATARI GUGGULU,HINGASTAK CHURNA AND BRIHAT SAINDHAVADYA TAILA IN THE MANAGEMENT OF RHEUMATOID ARTHRITIS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr DIPSUNDAR SAHU 
Designation  RESEARCH OFFICER (AYURVEDA) 
Affiliation  CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES, JANAKPURI, NEW DELHI 
Address  NATIONAL RESEARCH INSTITUTE OF AYURVEDIC DRUG DEVELOPMENT,BHARATPUR,BHUBANESWAR- 751003ORISSA

Khordha
ORISSA
BHUBANESWAR- 751003,
India 
Phone  8895173999  
Fax  0674-2386702  
Email  drdssahu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr DIPSUNDAR SAHU 
Designation  RESEARCH OFFICER(AYURVEDA) 
Affiliation  CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES, JANAKPURI, NEW DELHI 
Address  NATIONAL RESEARCH INSTITUTE OF AYURVEDIC DRUG DEVELOPMENT,BHARATPUR,BHUBANESWAR- 751003 ORISSA

Khordha
ORISSA
BHUBANESWAR- 751003,
India 
Phone  8895173999  
Fax  0674-2386702  
Email  drdssahu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr DIPSUNDAR SAHU 
Designation  RESEARCH OFFICER(AYURVEDA) 
Affiliation  CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES, JANAKPURI, NEW DELHI 
Address  NATIONAL RESEARCH INSTITUTE OF AYURVEDIC DRUG DEVELOPMENT,BHARATPUR,BHUBANESWAR- 751003 ORISSA

Khordha
ORISSA
BHUBANESWAR- 751003,
India 
Phone  8895173999  
Fax  0674-2386702  
Email  drdssahu@gmail.com  
 
Source of Monetary or Material Support  
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES (Deptt.of AYUSH,Ministryv of Health & family welfare,Govt.of India)Jahar Lal Neheru Bharatiya Chikitsa Evam Homeopathy Anusandhan Bhawan,No.61-65,Institutional Area,Opp,DBlock,Janakpuri,New Delhi  
 
Primary Sponsor  
Name  CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES  
Address  Jahar Lal Neheru Bharatiya Chikitsa Evam Homeopathy Anusandhan Bhawan,No.61-65,Institutional Area,Opp,DBlock,Janakpuri,New Delhi  
Type of Sponsor  Research institution and hospital 
 
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 
DrAlok SrivastavPrincipal Investigator  AYURVEDIC REGIONAL RESEARCH INSTITUTE,  AYURVEDIC REGIONAL RESEARCH INSTITUTE,AGAMKUAN,PATNA
Patna
BIHAR 
09792913313

aks_ro@rediffmail.com 
DrDipsundar SahuPrincipal Investigator  NATIONAL RESEARCH INSTITUTE OF AYURVEDIC DRUGS DEVELOPMENT  OUT PATIENT DEPARTMENT (OPD) OF NATIONAL RESEARCH INSTITUTE OF AYURVEDIC DRUGS DEVELOPMENT,BHARATPUR,BHUBANESWAR,751003 ODISHA Khordha ORISSA
Khordha
ORISSA 
8895173999
0674-2386702
drdssahu@gmail.com 
DrTapasi BorahPrincipal Investigator  North Eastern India Ayurvedic Research Institute  OUT PATIENT DEPARTMENT (OPD) OF North Eastern India Ayurvedic Research Institute,Borsojai(Bhetapara),Beltola,Guwahati
Kamrup
ASSAM 
9435014493
03612303714
t.borah09@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
ARRI,ETHICAL COMMITTEE  Approved 
NEIARI,ETHICAL COMMITTEE  Approved 
NRIADD,ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Rheumatoid arthritis patients having at least 4 out of 7 criteria American Rhumatology association ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1.VATARI GUGGULU 2.HINGVASTAKA CHURNA 3.BRIHAT SAINDHABADYA TAILA  1.VATARI GUGGULU-1 GRAM ORALLY THRICE DAILY FOR 12 WEEKS 2.HINGVASTAKA CHURNA-3 GRAMS ORALLY TWICE DAILY FOR 12 WEEKS 3.BRIHAT SAINDHABADYA TAILA-20 ML LOCAL APPLICATION TWICE DAILY FOR 12 WEEKS  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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 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 week duration).
c) Arthritis of hand joints, at least 1 area in wrist and hand is swollen (more than 6 week duration).
d) Symmetric arthritis (more than 6 week 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 to give written informed consent to participate in the study for 16 weeks including 4 weeks without drug follow-up

 
 
ExclusionCriteria 
Details  1. Patients who have developed complications of Rheumatoid Arthritis e.g. deformity of joints / bones, pleura-pericardial disease, or else.
2. Patients of juvenile rheumatoid Arthritis diagnosed before the age of 16 years.

3. Patients who are unable to walk without support and / or confined to wheel chair.
4. Patients suffering with Diabetes Mellitus (HbA1c > 6.5).
5. Patients diagnosed with other arthritis like gouty arthritis, tuberculous arthritis etc.
6. 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.
7. Patients who have a known history of Cardiovascular diseases.
8. 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 >1.4mg/dL), Pulmonary Dysfunction (Uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]),
9. Alcoholics and/or drug abusers.
10. H/o hypersensitivity to any of the trial drugs or their ingredients.
11. Pregnant / lactating woman.
12. Patients who have completed participation in any other clinical trial during the past six months.
13. Any other condition which the 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 
Primary Outcome Measure

• Changes in DAS-28 score

 
DAY 1,EVERY 14 DAYS UPTO 84 DAYS AND ON 112TH DAY  
 
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
 
Total Study Period 12 months
Washout / Preparatory Period (if required) 1 month
Recruitment 6 months
Treatment Period 12 weeks
Follow-Up Period 4 weeks
Statistical Analysis 1 month
 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   01/12/2014 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NONE YET  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Aim of research: To evaluate the clinical efficacy and safety of Vatari Guggul, Hingvastak Churna and Brihat Saindhavadi Taila in Amavata (Rheumatoid Arthritis).
Amavata, a poly articular joint disease which is characterised by a group of clinical features like angamarda (body ache), aruchi (anorexia), trisna (thirst), alasya (malaise), gouravam (feeling of heaviness), jwara (fever), apaka (indigestion) and angasunata(inflammation of the body parts)1 has resemblance with Rheumatoid arthritis. Rheumatoid arthritis is a chronic multisystem disease characterized by persistent inflammatory synovitis, usually, involving peripheral joints in a symmetric distribution. The potential of synovial inflammation to cause cartilage destruction and bone erosions & subsequent changes in joint integrity is the hallmark of the disease. Exact aetiology of Rheumatoid arthritis is unknown. Although recent work has focused on the possible role of super antigens produced by a number of microorganism including staphylococci, streptococci and mycoplasma arthritidis, other possible etiology mechanism in RA include a breakdown in normal self tolerance leading to reactivity to self antigens in the joint such as type-II collagen or loss of immuno regulatory control mechanism resulting in polyclonal ‘T’ cell activation. Super antigens are proteins with the capacity to bind to HLA-DR molecules and particular V segments of the heterodiametric T cell receptor and stimulate specific T cell expressive the V gene products. Of all the potential environmental triggers, the one only clearly associated with the development of RA is cigarette smoking. Rheumatism arthritis effect females in three times more than males it generally occurs in late third or fourth decade of their life spans2.
There is no known cure for Rheumatoid arthritis in modern system of medicine, however, the goal of treatment is to reduce joint inflammation and pain, maximise joint function and prevent joint destruction and deformity. Therefore, analgesic and anti inflammatory drugs as first line therapy and Disease Modifying Anti Rheumatic Drugs (DMARD) as second line therapy are used for the management of the disease condition. Whereas, the principle of treatment of Amavata in Ayurveda is etiologically oriented. Since, Agnimandhya - Grahani Dosa has been considered to be the main factor in pathogenesis of this disease, the correction of the gastro-intestinal function is more important to reduce severity and chronicity of the disease.  Owing to the gravity of the situation, a need is felt for searching the safe /effective Ayurvedic formulations to reduce the symptoms. Numbers of clinical trials have been done with single/compound, herbal, herbo-mineral medicines to evaluate their efficacy in the management of the disease. Some of the medicines tried in various institutes of CCRAS and other research institutes are (i) Sunthi Guggulu, (ii) Yogaraj Guggulu, Amavatari Rasa and Maharasnadi Kwatha, (iii) Rasnadi Kwatha, (iv) Musta Churna and Baluka sweda, (v) Aswagandha Churna, (vi) Mahayogaraj Guggulu and Vaiswanara Churna (vii) Simhanaada Guggulu and Brihata Saindhavadi Taila etc. Keeping all these view in consideration and the public health needs, a open clinical trial on the combined effect of 2 classical formulations referred in Ayurvedic Pharmacopeia of India (API)  have been selected to study the clinical efficacy and safety on Amavata Vatari Guggulu(API Part-II; VOL-II) Daily dose/patients- 1 gram (2 tablets of 500mg each) thrice daily , Hingvastaka Churna(API Part-II; VOL-I), Daily dose/patients –1 gm twice daily. Brihat Saindhavadi Taila (API Part-II; VOL-III), Daily dose/patients –20 ml  twice daily for local application for 12 weeks.


  
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