| CTRI Number |
CTRI/2024/09/073529 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Other (Specify) [RHEUMATOID ARTHRITIS] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clincal Study to evaluate the efficacy of katu tail bhrist aragvadha patra (Cassia fistula Linn.) in Gathiyavat (RHEUMATOID ARTHRITIS) |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy of katu tail bhrist aragvadha patra (Cassia fistula Linn.) in the management of Amavata (RHEUMATOID ARTHRITIS) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kumar Vikram Sahu |
| Designation |
PG Scholar |
| Affiliation |
Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh 492010 INDIA |
| Address |
Department of Dravyagun vigyan
Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh
492010
INDIA
Raipur
CHHATTISGARH
492010
India |
| Phone |
7587846800 |
| Fax |
|
| Email |
krvikrambs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Markam |
| Designation |
Lecturer in department of Dravyagun vigyan |
| Affiliation |
Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh 492010 INDIA |
| Address |
Room no 05 New PG Building Department of Dravyagun vigyan
Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh
492010
INDIA
Raipur
CHHATTISGARH
492010
India |
| Phone |
9340488469 |
| Fax |
|
| Email |
jyoti.markam23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjip Kumar Dass |
| Designation |
Professor & H.O.D Department of panchkarma |
| Affiliation |
Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh 492010 INDIA |
| Address |
OPD no.09 panchakarma, ground floor
Shri Khudadad Dungaji Govt.Ayurved College and Hospital,Raipur Chhattisgarh
INDIA
Raipur
CHHATTISGARH
492010
India |
| Phone |
8770014638 |
| Fax |
|
| Email |
drranjipayu@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Dravyagun vigyan
Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh
492010
INDIA |
|
|
Primary Sponsor
|
| Name |
Shri khudadad dungaji government ayurved hospital |
| Address |
Shri Narayan Prasad Awasthi Goverment Ayurved College GE Road opposite NIT Raipur Chhattisgarh
492010
INDIA |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Dravyagun vigyan |
Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur GE Road opposite NIT Raipur Chhattisgarh
492010
INDIA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kumar Vikram Sahu |
Shri Khudadad Dungaji Government Ayurved college hospital Raipur Chhattisgarh |
OPD No 09 Ward no 1&2 Department of panchkarma
Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur GE Road opposite NIT Raipur Chhattisgarh
492010
India
Raipur
CHHATTISGARH |
7587846800
krvikrambs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Shri Narayan Prasad Awasthi Goverment Ayurved college Raipur Chhattisgarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M069||Rheumatoid arthritis, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Aragvadha patra, Reference: Bha.pra.chi.26/52, Route: Oral, Dosage Form: Kalka/ Paste , Dose: 5(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: may take ushnajal), Additional Information: patra should be fried with sarshap tail |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients based on clinical symptoms mentioned in classical text book of ayurveda and modern
Patients who has given consent for clinical trai. |
|
| ExclusionCriteria |
| Details |
Patients of age below 18 years and above 60 years.
Patients who developed secondary complications of Rheumatoid Arthritis.
Pregnant and lactating mother.
Patients suffering from chronic renal failure, Tuberculosis, Carcinoma, |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Will reduce the symptoms of Rheumatoid Arthritis like pain swelling and redness of joints, will cure general weakness |
40 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improve the quality of life |
40 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
18/09/2024 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ayurveda, the science of life with a holistic approach to health and personalised medicine, it is one of the ancient medical science which comprises thousands of medical concepts and hypothesis. Health in Ayurveda is achieved by Dhatusamyata which is result of following code of conduct of Ayurveda like Dincharya, Ritucharya, Trayaupstambh, etc. Disturbance in above leads to disease, often all disease of Udar are result of Mandagni which occurs due to Apathya Sevan results in formation of Aam & it can be defined as Adya Ras which is incompletely or partially digested that results in disequilibrium of Dosha, Dhaatu and Mala which results in many diseases and Amavata is one among them. The term Amavata comprises of two vitals words Aam and Vata. Virulent Aam circulates in the whole body propelled by the vitiated Vata dosa’s producing Strotoavrodh in the Dhamni causing Sthanasmsraya manifested Stabdhata, Sandhishool, Sandhisotha, Angamard, Apaka, Anggaurav, Jwar, Alasya etc symptoms of Amavata. Viruddhaahar, Nishchalata and Mandagni are the main etiological factors of Amavata producing toxin Aam which is not homogeneous for the body whenever the Aam get localised in the body tissue or joints with aggravated vata it can lead to production of pain, stiffness and swelling.Many symptoms of rheumatoid arthritis keeps clinical similarity with Amavata. Rheumatoid arthritis is an autoimmune disease that causes chronic inflammation of joints and tissue around them the other cardinal sign includes fatigue, morning stiffness, severe muscle and joint pain, anorexia and weakness, because of its potential of affecting multiple organs of body Rheumatoid arthritis is referred as systemic illness. The prevalence of Rheumatoid arthritis has been reported to 1% in world and 0.75% in India with ratio of 1:3 in male and female respectively with common age group between 35 to 60 years Diseased conditions are cured by Ausadh Sevan either by Yog or single Dravya. We get many references of disease being cured by single drug from Samhitas. Leaves of Aragvadha are fried with mustard oil and are taken before or with evening meal helps in reducing Aam and Vata.
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