| CTRI Number |
CTRI/2018/07/015025 [Registered on: 24/07/2018] Trial Registered Prospectively |
| Last Modified On: |
07/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
CLINICAL EVALUATION OF EFFICACY OF INDUKANTA GHRITA AND TRAYODASHANG GUGGULU IN THE TREATMENT OF RHEUMATOID ARTHRITIS |
|
Scientific Title of Study
|
CLINICAL EVALUATION OF INDUKANTA GHRITA AND TRAYODASHANG GUGGULU IN THE MANAGEMENT OF RHEUMATOID ARTHRITIS VIS –A–VIS AMAVATA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishna RaoS |
| Designation |
RESEARCH OFFICER(Ay) |
| Affiliation |
NATIONAL AYURVEDA RESEARCH INSTITUTE FOR PANCHAKARMA |
| Address |
NATIONAL AYURVEDA RESEARCH INSTITUTE FOR PANCHAKARMA
CHERUTHURUTHY
CHERUTHURUTHY PO
THRISSUR
KERLA
Thrissur
KERALA
679531
India |
| Phone |
9037690951 |
| Fax |
|
| Email |
krdrkrishnarao@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna RaoS |
| Designation |
RESEARCH OFFICER(Ay) |
| Affiliation |
NATIONAL AYURVEDA RESEARCH INSTITUTE FOR PANCHAKARMA |
| Address |
NATIONAL AYURVEDA RESEARCH INSTITUTE FOR PANCHAKARMA
CHERUTHURUTHY
CHERUTHURUTHY PO
THRISSUR
KERLA
Wayanad
KERALA
679531
India |
| Phone |
9037690951 |
| Fax |
|
| Email |
krdrkrishnarao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna RaoS |
| Designation |
RESEARCH OFFICER(Ay) |
| Affiliation |
NATIONAL AYURVEDA RESEARCH INSTITUTE FOR PANCHAKARMA |
| Address |
NATIONAL AYURVEDA RESEARCH INSTITUTE FOR PANCHAKARMA
CHERUTHURUTHY
CHERUTHURUTHY PO
THRISSUR
KERLA
KERALA
679531
India |
| Phone |
9037690951 |
| Fax |
|
| Email |
krdrkrishnarao@gmail.com |
|
|
Source of Monetary or Material Support
|
| CENTRAL CONCILFOR RESEARCH IN AYURVEDIC SCIENCES
61-65 INSTITUTIONAL AREA
JANAKPURI
NEW DELHI-110058 |
|
|
Primary Sponsor
|
| Name |
CCRAS |
| Address |
61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi, Delhi 110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Remya E |
National Ayurveda Research Institute for Panchakarma |
OP DEPARTMENT,New Building,OPD NUMBER 1
Cheruthuruthy P.O, Thrissur, Kerala, 679531
Thrissur
KERALA |
9447378133
drremyaenair@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC OF NARIP Cheruthuruthy |
Approved |
| IEC, NARIP CHERUTHURUTHY KERALA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
RHEUMATOID ARTHRITIS VIS –A–VIS AMAVATA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INDUKANTA GHRITA
TRAYODASHANG GUGGULU |
1. Indukanta Ghrita (API Part II, Vol-II Pg. no. 96-99)
Dose : 10 gm BD (30 minutes before meal)
Dosage form : Ghrita
Anupan : Warm water
Route of Administration : Oral
Duration of therapy : 12 weeks
Trayodashang Guggulu (API Part II, Vol-II Pg. no. 132-133)
Dose : 1.5 gm (3 tablets of 500mg each) BD
Dosage form : Tablet
Route of Administration : Oral
Time of Administration : Twice a day after food
Anupana : Lukewarm Water
Duration of therapy : 12 weeks
Comparator Agent not applicable
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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 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
r
adiograph that must include erosions or unequivocal bony decalcification,
localized in or adjacent to involved joints.
3) Adult onset
4 ) Duration of establish diseases > 2 years.
5) Patients willing to give written informed consent to participate in the study for 12 weeks
|
|
| ExclusionCriteria |
| Details |
1. Patients who have developed complications of Rheumatoid Arthritis e.g deformity of joints/bones, pleura pericardial diseases, 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 (140/90 mmHg)
5. Patients suffering with uncontrolled Diabetes mellitus (HBA1c > 6.5%)
6. Patients diagnosed with other arthritis like gouty arthritis, tuberculosis arthritis etc.
7. 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.
8. Patients who have 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 disorders (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 more than upper limit of normal >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 months
15. 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 |
Changes in DAS-28 score
|
At Baseline, 15th day, 29th day, 43rd day, 57th day, and 71th 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
Patient’s global assessment of diseases activity.
Physician’s global assessment of diseases activity
Pain VAS scale ( Visual Analogue Scale) (0-100)
Any adverse drug reaction or adverse event
|
At Baseline, 15th day, 29th day, 43rd day, 57th day, and 71th day.
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
26/07/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The study is a open Clinical trial to evaluate the efficacy and safety of Indukantha ghritha(10 gm twice daily) and Trayodashang Guggulu (3 gutika of 500mg )in management of Rheumatoid Arthritis vis a vis Amavata in 50 patients each at NARIP,Cheruthuruthy and CARIID, Kolkota.The total duration of study is 2 years and the intervention for 12 weeks.The primary outcome measure is the DAS-28 score.The secondary outcome measure will be Changes in Disability Index,ESR 7 CRP,,Global assessment of disease activity ,Pain VAS scale (at Baseline and on 15th,29th,43rd,57th and 71st day ),Questionnaire SF36(At baseline and 85th day). Clinical trial was completed. 50 subjects were enrolled. 48 subjects completed the trial and 2 subjects dropped out from study. Statistical analysis of the data & publication of clinical findings are remaining. |