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CTRI Number  CTRI/2025/02/080745 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 31/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to assess the pain reducing effect of a herbal drink in rheumatoid arthritis 
Scientific Title of Study   A CLINICAL EVALUATION OF ADD ON EFFECTIVENESS OF NIRGUNDYADI SIDDHA JALA AS PATHYA IN MANAGING PAIN IN 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 Padmini Babu 
Designation  PG Scholar,Dept of Swasthavritta 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  Department of Swasthavritta Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9447111946  
Fax    
Email  pg23152@sdmcahhassan.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Shivakumar 
Designation  Associate Professor,Dept of Swasthavritta 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  Department of Swasthavritta Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9886259437  
Fax    
Email  drshivakumar@sdmcahhassan.org  
 
Details of Contact Person
Public Query  
Name  Dr Shivakumar 
Designation  Associate Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  Department of Swasthavritta Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9886259437  
Fax    
Email  drshivakumar@sdmcahhassan.org  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital thanniruhalla BM Road Hassan 573201 Karnataka India 
 
Primary Sponsor  
Name  SDM College of Ayurveda and Hospital Hassan 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India 
Type of Sponsor  Private medical college 
 
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 Padmini Babu  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan  Department of Swasthavritta In patient department BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA 		 9447111946

pg23152@sdmcahhassan.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassas 573201 Karnataka India  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
1Comparator ArmDrugClassical(1) Medicine Name: simhanada guggulu, Reference: bhaishajyaratnavali amavtadhikara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: nirgundyadi siddha jala, Reference: Bhavaprakasha, Route: Oral, Dosage Form: Dravaka, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion Criteria:
1. Age between 30 to 60 years.3
2. Gender- all
3. Both acute and acute on chronic patients. 
 
ExclusionCriteria 
Details  Exclusion Criteria :
1.Pregnant women and lactating mother.
2.K/C/O uncontrolled systemic diseases like HTN, Diabetes, Cradiovascular diseases, Tuberculosis, hypothyroidism etc. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
reduction in joint pain  1st day and 15th day 
 
Secondary Outcome  
Outcome  TimePoints 
pain reduction through diet without the help of medicines  1st day and 15th 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 2/ Phase 3 
Date of First Enrollment (India)   01/03/2025 
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="6"
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  

Pathya plays a paramount role in leading a healthy lifestyle.


  • The Concept of Nutraceuticals ages back to ancestral periods where food was used as medicine too.1

  • This study is an attempt to transform one of the formulations said in the Ayurvedic classics into Pathya, considering the chance of wider accepatance and popularity among people.


  • RA is a systemic autoimmune disease characterized by chronic inflammation, in which the main symptom is pain.2


  • About 0.8% of world’s population and 0.75% of India’s population are affected by R.A.3


  • Up to 90.4% of RA patients visit a health professional for severe pain.2


  • Despite new therapies and sophisticated treatments, there are a limited number of options for analgesic management.2


  • Due to wide spectrum of this disease, much prevalence in the society and lack of effective medicament this disease is being chosen for the study.


  • As per the Ayurvedic classics, Amavata shows close resemblance to R.A due to similarity in clinical features.3


  • Many Ayurvedic formulations are claimed to be effective in Amavata, however, scientific evidence needs to be produced.


  • The Kwatha of Nirgundi, Rasona and Shunthi is one such preparation that has been described in Amavataadhikara of Bhavaprakasha.4


  • Considering the ready availability of above said drugs in households and the agonising pain perceived by patients suffering from this disease, an attempt is made to evaluate the add on effectiveness of Nirgundyadi siddha jala for managing pain in Rheumatoid Arthritis, where drugs will be used in dry form.


 
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