| CTRI Number |
CTRI/2024/09/074459 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Diagnostic Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Pathya Ahara (Wholesome Diet) in AMAVATA(Rheumatoid Arthritis). |
|
Scientific Title of Study
|
A Randomised Open Label Controlled Clinical Study to Evaluate the Efficacy of Pathya Ahara along with Rasonadi Kwatha and Rasonadi Kwatha alone in the management of Amavata with special reference to 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 Kajal Raskotra |
| Designation |
PG scholar |
| Affiliation |
Jammu Institute of Ayurveda and Research Jammu |
| Address |
Dept.of PG Studies in KayaChikitsa Jammu Institute of Ayurveda and Research,Kot bhalwal road Nardani jammu and Kashmir
Jammu JAMMU & KASHMIR 181123 India |
| Phone |
8082091323 |
| Fax |
|
| Email |
kajalraskotra2@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Poonam Gupta |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Jammu Institute of Ayurveda and Research Jammu |
| Address |
PG KC DEPARTMENT OF JAMMU INSTITUTE OF AYURVEDA AND RESEARCH KOT BHALWAL NARDANI JAMMU and KASHMIR
Jammu JAMMU & KASHMIR 181123 India |
| Phone |
9149696904 |
| Fax |
|
| Email |
drpoonamgupta03@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Poonam Gupta |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Jammu Institute of Ayurveda and Research Jammu |
| Address |
PG KC DEPARTMENT OF JAMMU INSTITUTE OF AYURVEDA AND RESEARCH KOT BHALWAL NARDANI JAMMU and KASHMIR
Jammu JAMMU & KASHMIR 181123 India |
| Phone |
9149696904 |
| Fax |
|
| Email |
drpoonamgupta03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jammu Institute of Ayurveda and Research, Jammu 181123 India |
|
|
Primary Sponsor
|
| Name |
Jammu Institute of Ayurveda and Research Jammu |
| Address |
Kot bhalwal ,NARDANI , jammu , jammu & kashmir 181123 India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kajal Raskotra |
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU |
Room no.102 first floor Department of Kayachikitsa, JIAR , 181123 Jammu JAMMU & KASHMIR |
8082091323
kajalraskotra2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasonadi kwatha with pathya ahara in amavata, Reference: Bhavprakash(Rasonadi kwatha), bheshajya ratnawali , chakradutta , yogratnakar (pathya ahara amavat), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasonadi kwatha, Reference: Bhavprakash , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having Cardinal Signs and Symptoms of Amavata will be considered for
present study
2. Patients of both the gender between the age group of 16-60 years presenting
Clinical
3. Patients who follow the American College of Rheumatology (ACR) 2010 Criteria.
|
|
| ExclusionCriteria |
| Details |
Patients aged below 16 years and above 60 years.
2. Gout, Osteoarthritis, Ankylosing Spondylitis, Osteomyelitis
3. Pregnant and lactating women.
4. Arthritis with malignancy.
5. Psoriatic Arthritis, Rheumatic fever, Asymmetrical Arthritis.
6. Ulnar deviation, Swan neck deformity of wrist and elbow.
7. Patient suffering from other systemic complicated diseases like Diabetes Mellitus,
Pulmonary Tuberculosis, Hyperthyroidism, Hypothyroidism etc.
|
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective Parameters:
The Signs and Symptoms of Amavata as per Ayurvedic classics:
 Sandhistabdhata (Morning stiffness)
 Sandhishoola (Pain)
 Sandhishotha (Swelling)
 Apaka (Indigestion)
Objective Parameters:
ï‚§ ESR
ï‚§ R.A Factor
ï‚§ CRP
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Range of movement of affected joints.
2.Number of joints involved |
Baseline,15th day ,30th day , 45th day |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
15/10/2024 |
| 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="0" Months="1" 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
|
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Brief Summary
|
Health is supreme foundation for the achievement of happy life. The sedentary life style of today’s era has increased the risk of certain disorders like diabetes, hypertension and joint pathologies. The disorders affecting the locomotory system are increasingly seen in the present time. Among such disorders Ayurveda classics have described a debilitating disease called AMAVATA. It is not only a disorder of the locomotor system, but is also a systemic disease and is named after its chief pathogenic constituents, which are, Ama and Vata. The disease typically manifests itself with localized symptoms like Sandhishoola, Shotha and Stabdhata in the joints of Hasta, Pada-Shira, Gulpha, Janu, Trika and Uru along with symptoms of systemic manifestation like Angamarda. Aruchi, Trushna, Aalasya, Gourava, Jwara, Apaka and Angashoonata1 . The disease ‘Amavata’ resembles the aetiopathogenesis and clinical picture observed in Rheumatoid Arthritis of conventional medicine2 . Rheumatoid Arthritis which is a systemic chronic inflammatory joint disorder which affects predominantly the synovial joints. Cardiac involvement, symmetrical involvement of joints along with Pain, Stiffness and Swelling with number of systemic complication resembles the disease Amavata . Pathya,which is the Aahar- vihar that calms the mind, is beneficial to the body, and provides nutrients, and Apathya, which is the opposite of Pathya 3 (Ch . Su 25 / 45 ). Importance of Pathya : Acharya Charaka had detailed Pathya as a synonym for treatment4 . He mentioned that when channels of circulation become hard by aggravated Doshas and Pathya helps to soften the Srotasas and alleviate vitiated dosha5. |