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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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: -
2Comparator ArmDrugClassical(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: -
 
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.
 
 
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
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.
 
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