CTRI Number |
CTRI/2017/04/008397 [Registered on: 24/04/2017] Trial Registered Retrospectively |
Last Modified On: |
23/04/2017 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Case Control Study |
Study Design |
Other |
Public Title of Study
|
OBSERVATIONAL STUDY OF NIDANA PANCHAKA OF AMAVATA WITH SPECIAL REFERENCE TO RHEUMATOID ARTHRITIS |
Scientific Title of Study
|
OBSERVATIONAL STUDY OF NIDANA PANCHAKA OF AMAVATA WITH SPECIAL REFERENCE TO 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 |
B Arun Prakash |
Designation |
PG scholar |
Affiliation |
Parul Institute Of Ayurveda, Parul University |
Address |
Department of Roga Vignana evum vikruti vignana, Parul Institute Of Ayurveda, Parul University, Limda Parul University, Limda Vadodara, GUJARAT,391760, India.
Vadodara GUJARAT 391760 India |
Phone |
9944348235 |
Fax |
|
Email |
arundoctorarun@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Harish soni |
Designation |
Professor |
Affiliation |
Parul Institute Of Ayurveda, Parul University |
Address |
Department of kaya chikitsa, Parul Institute Of Ayurveda, Parul University, Limda Parul University, Limda Vadodara, GUJARAT,391760, India.
Vadodara GUJARAT 391760 India |
Phone |
7878374848 |
Fax |
|
Email |
haresh.soni@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
Name |
Dr Harish soni |
Designation |
Professor |
Affiliation |
Parul Institute Of Ayurveda, Parul University |
Address |
Department of kaya chikitsa, Parul Institute Of Ayurveda, Parul University, Limda Parul University, Limda Vadodara, GUJARAT,391760, India.
Vadodara GUJARAT 391760 India |
Phone |
7878374848 |
Fax |
|
Email |
haresh.soni@paruluniversity.ac.in |
|
Source of Monetary or Material Support
|
Parul Institute Of Ayurveda |
|
Primary Sponsor
|
Name |
Parul institute of Ayurveda and Hospital |
Address |
Parul University,
Limda,Vadodara |
Type of Sponsor |
Private medical college |
|
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 |
BArun Prakash |
Parul Institute Of Ayurveda |
Parul Institute Of Ayurveda,
Panchakarma op no 113
Kaya chikitsa 106
Parul University, Limda Vadodara, GUJARAT,391760, India. Vadodara GUJARAT |
9944348235
arundoctorarun@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
institunal ethical comittee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
RHEUMATOID ARTHRITIS, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patient with classical signs and symptoms of amavata as per ayurveda will be selected.
Patients of age group between 25 to 60 years.
Patients will be selected irrespective of their gender and religion.
Patients will be selected both seropositive and seronegative.
|
|
ExclusionCriteria |
Details |
Patients of age group > 60 and < 25 years.
Patients with any other major illnesses e.g. osteoporosis, osteoarthritis, gouty arthritis.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
|
Blinding/Masking
|
|
Primary Outcome
|
Outcome |
TimePoints |
To find out the cause of the disease |
one day |
|
Secondary Outcome
|
Outcome |
TimePoints |
Angamardha (Body Ache)
Aruchi (Loss Of Taste)
Trishna (Thirst)
Alasya (Laziness)
Gaurava (Heaviness)
Jvara (Fever)
Apaka (Indigestion)
Shoonata Anganam(Numbness)
Stabdata (Stiffness)
|
one day |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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
|
N/A |
Date of First Enrollment (India)
|
02/03/2017 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
NOT YET DONE |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
HYPOTHESIS: There is a relation between nidana panchaka of amavata and rheumatoid arthritis
Rheumatoid arthritis affects 15% people i.e over 180 million people in India. This prevalence is higher than many well known diseases such as diabetes, cancer and AIDS. It can affect many facets of a patient’s life, viz. his family, occupational and community relationships even. It affects not only the social and economic position of the individual and his family but it leads to the draining of national resource due to the work hours lost, resulting in diminished production. Rheumatoid arthritis is the second most common type of arthritis, 70 percent of the patients who have the disease is woman. Rheumatoid arthritis usually develops between the age of 30 and 50 but it can occur at any age. In present era, enormous changes are noted in life style, food habits, working pattern, sleep pattern, stress level etc. These all factors are becoming common causative factors of so many diseases. Also, new food article are added in routine life of so many individuals, so new etiological factors are always at increasing part. These newly added etiological factors are to be identified and have to be added as extra etiological factors of respective disease because of every person indulging in improper food (Viruddhahara) and activities causes provocation of Vata dosha and Agni dusti, by these prime factors a primordial disease manifesting factor developed known as amavata
Here we will study the nidan panchak of aamavata with special reference to rheumatoid arthritis. This will definitely shed light on nidan panchak of amavata specially hetu which are found now a days. This will help in treatment.
|