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CTRI Number  CTRI/2023/05/053041 [Registered on: 23/05/2023] Trial Registered Prospectively
Last Modified On: 22/05/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   ayurvedic aetiopathogenesis of amavata with therapeutic effect of pathyadi churna 
Scientific Title of Study   Nidanpanchatamak Study Of Amavata [Rheumatoid Arthritis] With Upasayatmaka Effect Of Pathyadi Churna w.s.r. To Biological Marker 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashu 
Designation  Ph.D. Scholar 
Affiliation  Guru Ravidas Ayurved University Punjab 
Address  Vaidya Yagya Dutt Sharama Ayurvedic College Khurja Bulandshahar
Guru Ravidas Ayurved University VPO Kharkan Una Road Hoshiarpur Punjab
Bulandshahar
UTTAR PRADESH
203131
India 
Phone  9318809011  
Fax    
Email  dr.ashu007@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  vaidya Rakesh Sharma 
Designation  Professor 
Affiliation  Guru Ravidas Ayurved University Punjab 
Address  President of BERISM National Commission of Indian System of Medicine 61-65 Institutional Area Janak Puri Delhi
Guru Ravidas Ayurved University VPO Kharkan Una Road Hoshiarpur Punjab
West
DELHI
110058
India 
Phone  9814779242  
Fax    
Email  president.berism@ncismindia.org  
 
Details of Contact Person
Public Query  
Name  Dr Ashu 
Designation  Ph.D. Scholar 
Affiliation  Guru Ravidas Ayurved University Punjab 
Address  Vaidya Yagya Dutt Sharama Ayurvedic College Khurja Bulandshahar
Guru Ravidas Ayurved University VPO Kharkan Una Road Hoshiarpur Punjab
Bulandshahar
UTTAR PRADESH
203131
India 
Phone  9318809011  
Fax    
Email  dr.ashu007@yahoo.com  
 
Source of Monetary or Material Support  
Vaidya Yagya Dutt Sharma Ayurved College Khurja District Bulandshahar UP 203131 
 
Primary Sponsor  
Name  Dr Ashu 
Address  Vaidya Yagya Dutt Sharma Ayurvedic College Khurja Bulandshshar 
Type of Sponsor  Other [SELF] 
 
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 Ashu  Dept. Of Rog Nidan and Vikriti Vigyan Vaidya Yagya Dutt Sharma Ayurved College   Dharpa GT Road Khurja Dist. Bulandshahar
Bulandshahar
UTTAR PRADESH 		 9318809011

dr.ashu007@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Guru Ravidas Ayurved University Hoshiarpur Punjab and VYDS Ayurved College Khurja   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement. Ayurveda Condition: AMAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Pathyadi Churna, Reference: Bhava Praksaha Amavata Chikitsa 26-37-38, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Angamardha, Aruchi, Trishna, Alasya, Gaurava, Jwara, Apaka, Sandhi Shotha, and 2010 ACR-EULAR classification criteria for Rheumatoid Arthritis.
2. Subjects aged between 20-60 years
3. Subjects of either gender
4. Subjects willing to participate in the study and ready to sign informed consent form. 
 
ExclusionCriteria 
Details  1. Subjects with known case of essential hypertension and uncontrolled diabetes mellitus
2. Subjects with known case of impaired renal, hepatic and cardiac function
3. Subjects with known case of systemic arthritis (gout, tubercular arthritis, systemic lupus erythematosus, psoriatic arthritis)
4. Pregnant and Lactating women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
A joint involvement (0–5 points)
1 large joint 0
2–10 large joints 1
1–3 small joints 2
4–10 small joints 3
10 joints including at least one small joint 5
B Serology 0–3 points
Negative RF and negative ACPA 0
Low positive RF or low positive ACPA 2
High positive RF or high positive ACPA 3
C Acute-phase reactants 0–1 point
Normal CRP and normal ESR 0
Abnormal CRP or abnormal ESR 1
D Duration of symptomsed
6 weeks 0
≥6 weeks 1  		 30 days
 
 
Secondary Outcome  
Outcome  TimePoints 
Ayurvedic Assessment parameter
1 Angamarda
2 Aruchi
3 Trishna
4 Alasya
5 Gaurava
6 Jwara
7 Apaka
8 Shotha
 		 30 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   31/05/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Introduction: The study is an open label, single arm, prospective clinical trial in Amavata (Rheumatoid Arthritis) (n=60) selected using the convenience (non-random) sampling technique with pre and post design          conducted in tertiary Ayurveda Hospital attached to VYDS Ayurveda Medical College located in district Bulandshahar India, irrespective of caste, sex, occupation and socio-economic status etc.
Diagnostic Criteria : Angamarda, Aruchi, Trishna, Alasya, Gaurava, Jwara, Apaka, Sandhi Shotha, and 2010 ACR-EULAR 114 classification criteria for Rheumatoid Arthritis with grading score.
LABORATORY INVESTIGATION: ESR, (Hb gm %),Urine Analysis, Serum uric acid level was estimated to rule out the possibility of other pathological conditions.
Bio- Markers :Rheumatoid Factor (RF), C- Reactine Protein (CRP).
POSOLOGY: Drug- Pathyadi Churna (Bhavaprakash ) 3g BID with Luke warm water For 30 days.
FINAL ASSESSMENT OF RESULT: Patients will be assessed before & after the treatment (30 days) for improvement in symptoms on the basis of said scoring pattern & percentage improvement would be calculated.



 
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