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CTRI Number  CTRI/2026/01/100528 [Registered on: 08/01/2026] Trial Registered Prospectively
Last Modified On: 02/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to assess the effect of Rasna Panchaka Ghana Vati and Trayodashanga Guggulu in reducing knee pain in patients with knee osteoarthritis 
Scientific Title of Study   An open label randomised control clinical study to assess the effectiveness of Rasna Panchaka Ghana Vati and Trayodashanga Guggulu in the management of pain in Janu Sandhigata Vata (Osteoarthiritis of Knee) after kosthashodhana 
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 Bushra Siddiqui 
Designation  MD Scholar 
Affiliation  All India Institute Of Ayurveda  
Address  Department Of Kayachikitsa 6th Floor Of Academic Block All India Institute Of Ayurveda,Gautampuri,Sarita Vihar,New Delhi

South
DELHI
110076
India 
Phone  9718045705  
Fax    
Email  siddiqui.bushra1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rama Kant Yadava 
Designation  Additional Professor 
Affiliation  All India Institute Of Ayurveda  
Address  Department Of Kayachikitsa 6th Floor Of Academic Block All India Institute Of Ayurveda,Gautampuri,Sarita Vihar,New Delhi

South
DELHI
110076
India 
Phone  9412148437  
Fax    
Email  drrkyadava@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bushra Siddiqui 
Designation  MD Scholar 
Affiliation  All India Institute Of Ayurveda  
Address  Department Of Kayachikitsa 6th Floor Of Academic Block All India Institute Of Ayurveda,Gautampuri,Sarita Vihar,New Delhi

South
DELHI
110076
India 
Phone  9718045705  
Fax    
Email  siddiqui.bushra1997@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Ayurveda,Gautampuri,Sarita Vihar,New Delhi 110076 
 
Primary Sponsor  
Name  All India Institute Of Ayurveda 
Address  Department Of Kayachikitsa 6th Floor Of Academic Block All India Institute Of Ayurveda,Gautampuri,Sarita Vihar,New Delhi 
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 Bushra Siddiqui  All India Institute of Ayurveda  Department Of Kayachikitsa 6th Floor Of Academic Block All India Institute Of Ayurveda ,Gautampuri,Sarita Vihar, New Delhi 110076
South
DELHI 		 9718045705

siddiqui.bushra1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M17||Osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Trayodashanga Guggulu, Reference: Bhaishajya Ratnavali Vatraktadhikara 89-92, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: -koshthashodhana with Eranda Taila 20-30ml orally once according to koshtha of patient before initiation of oral trial drug
2Intervention ArmDrugClassical(1) Medicine Name: Rasna Panchaka Ghana Vati, Reference: chakaradutta 24/7, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: -koshthashodhana with Eranda Taila 20-30ml orally once according to koshtha of patient before initiation of oral trial drug
 
Inclusion Criteria  
Age From  31.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient representing sign and symptoms Of Janu Sandhigata Vata
2.Patient aged between 31-60 years irrespective of sex and occupation
3.Patient willing to participate
 
 
ExclusionCriteria 
Details  1.Severe deformity or end-stage OA,Grade IV radiological changes.
2.Patients with uncontrolled systemic illnesses such as diabetes HBA1C more than 8, hypertension systolic BP more than 160mmhg and diastolic more than 100mmhg
3.Pregnant and lactating women
4.Secondary osteoarthritis due to trauma, infection, or metabolic disorders
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in pain intensity as measured by VAS from baseline to the end of the study period  Change in pain intensity as measured by VAS from baseline to the end of the study period 
 
Secondary Outcome  
Outcome  TimePoints 
•Functional Improvement: Assessed by the Westen Ontario and McMaster Universities Arthritis Index (WOMAC)
•Joint stiffness improvement: Measured via the stiffness Subscale of WOMAC.
•Change in Quality of Life (QoL) scores from baseline to the end of the study period (SF36 questionnaire).
 		 Outcome will be assessed at baseline to the end of the study period 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   15/01/2026 
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="0"
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  
Janu Sandhigata Vata, comparable to osteoarthritis of the knee, is a common degenerative joint disorder characterized by pain, stiffness, swelling, and restricted movements, especially affecting the elderly population. Conventional management mainly focuses on symptomatic relief using NSAIDs and physiotherapy, which may be associated with adverse effects and limited long-term benefits. Ayurveda offers a holistic approach through Shodhana and Shamana therapies for managing such chronic conditions.
This study is an open-label, randomized, controlled clinical trial designed to evaluate and compare the effectiveness of Rasna Panchaka Ghana Vati and Trayodashanga Guggulu in the management of pain in Janu Sandhigata Vata (osteoarthritis of knee) following Koshthashodhana. A total of 140 patients will be randomly allocated into two groups of 70 each. Both groups will undergo Koshthashodhana with Eranda Taila prior to oral medication. Group A will receive Rasna Panchaka Ghana Vati, while Group B will receive Trayodashanga Guggulu for four weeks, followed by a four-week follow-up period.
The primary outcome measure is improvement in pain intensity assessed using the Visual Analog Scale (VAS). Secondary outcomes include assessment of pain, stiffness, and physical function using the WOMAC index, subjective Ayurvedic parameters, quality of life (SF-36), and inflammatory markers such as ESR and CRP. The study aims to generate evidence-based data on the comparative efficacy and safety of these Ayurvedic formulations and contribute to integrative management strategies for knee osteoarthritis.
 
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