| CTRI Number |
CTRI/2016/12/007569 [Registered on: 14/12/2016] Trial Registered Retrospectively |
| Last Modified On: |
07/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of castor oil in the management of Rheumatoid arthritis. |
|
Scientific Title of Study
|
Efficacy of Erand sneh in the management of Amavata (Rheumatoid arthritis)w.s.r.to its sama stage. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gauridutt Mishra |
| Designation |
MD2nd Year Scholar |
| Affiliation |
IPGT RA GAU JAMNAGAR |
| Address |
Department of Roga nidana evam Vikriti Vijnana IPGT RA GAU Jamnagar PG Boys Hostel Room No 95
Jamnagar
GUJARAT
361008
India |
| Phone |
8511287036 |
| Fax |
|
| Email |
gauridutta@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Darshna Pandya |
| Designation |
Assistant Professor |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University JAMNAGAR |
| Address |
Department of Roga nidana evam Vikriti Vijnana Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar.
Department of Roga nidana evam Vikriti Vijnana Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar.
Jamnagar
GUJARAT
361008
India |
| Phone |
9099011095 |
| Fax |
0288-2676856 |
| Email |
darshnapandya@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gauridutt Mishra |
| Designation |
MD2nd Year Scholar |
| Affiliation |
IPGT RA GAU JAMNAGAR |
| Address |
Department of Roga nidana evam Vikriti Vijnana IPGT RA GAU Jamnagar PG Boys Hostel Room No 95
Jamnagar
GUJARAT
361008
India |
| Phone |
8511287036 |
| Fax |
|
| Email |
gauridutta@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar |
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar |
| Address |
Institute for Post Graduate Teaching and Research in Ayurveda GUJARAT AYURVED UNIVERSITY JAMNAGAR Gujarat India 361008 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Darshna Pandya |
OPD Building OPD No 26 |
Department of Roga nidana evam Vikriti Vijnana Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University
Jamnagar
GUJARAT |
9099011095
0288-2676856
darshnapandya@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
The Patients of disease Amavata having classical Sign and symptoms of Sama stage will be selected for the Study, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erand Sneha(castor oil) |
10 ml at Morning time orally for 15 days with Luke warm water |
| Comparator Agent |
Shunthi Kwatha and castor oil |
5 gm Sunthi Yavkuta at Morning Time after preparing shunthi kwath and adding 10 ml castor oil , oral route for 15 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the diagnostic criteria especially having symptoms of sama stage of disease
Willing & able to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Less than 20 & more than 60 years
2. Patients having symptoms of RA but having absence of Sama symptoms.
3. Patients with complication of RA e.g. Pleuro-Pericardial disease, cardiac disease etc.
4. Patients with poorly controlled HTN, DM etc.
5. Patients on prolong medication especially corticosteroids, anticholinergics etc.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| RELIEF OF Symptoms of Sama stage of disease AMAVATA i.e. pichhil mala tyaga , Ashradhdha, Aruchi, Angagaurav, Jwara, Asya Samsravana, Asya Pichchhilatva, Hrillasa etc. symptoms of RA (As mentioned according to revised criteria of American association of rheumatology 1987 ) with stiffness of affected joints , severe tenderness ,swelling of affected joints , redness (sero-positive or sero-negative) |
18 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| symptoms of RA (As mentioned according to revised criteria of American association of rheumatology 1987 ) with stiffness of affected joints , severe tenderness ,swelling of affected joints , redness . |
UPTO PRESENT STUDY |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "53"
Final Enrollment numbers achieved (India)="53" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/02/2016 |
| Date of Study Completion (India) |
20/02/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NO PUBLICATION |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
In 21st century Rheumatoid arthritis (RA) has been more common& distressing among all joints problem. About 1% of world population is affected by RA.Females are three times more affected than male. It is a chronic inflammatory joint disease with multi system involvement. Even in modern medical science with extreme advancement in diagnostic approach, only symptomatic relief and no permanent cure can be given. Hence for Ayurvedic scholar it is a challenging disease, so it becomes duty of scholars to work on various aspect of this disease. Rheumatoid Arthritis can be correlated with disease Amavata mentioned in Ayurvedic text book.All symptoms mention are characteristic of Ama & without treating Ama it is not possible to treat the disease so in this condition drug having Ushna, Tikshna, Deepan, Pachan, Vatashamak, Shothhara Properties can be used, when Ama is digested then drug having Vatashamak properties remain useful, only after digestion of Ama other drugs can be used. The property of Ama is Guru, Snigdha, Sheet, Pichchhil and Manda. In Ayurvedic classics Erand Sneha has been mentioned as drug of choice for the disease Amavata due to having its Katu, Tikshna, Ushna properties, Shunthi increase digestive fire, make interest toward food and pacify Vata and Kapha shamak properties. After completion of therapy it is found that in Sama condition (Acute stage) of disease Amavata (Rheumatoid arthritis) both Erand Sneh and Shunthi Kwath was found effective and provide better relief in subjective and objective parameters. Group A (Erand Sneh and Shunthi Kwath) was found more effective than group B ( only Erand Sneh) |