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CTRI Number  CTRI/2021/08/035880 [Registered on: 24/08/2021] Trial Registered Prospectively
Last Modified On: 18/08/2021
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   Clinical Study To Compare The Effect Of Salvana Upanaha Sweda(Paultice)And Shadanga Guggulu(Tablet) With Bala Ashwagandhadi Taila Janu Veshtana (Bandaging) And Shadanga Guggulu (Tablet) In The Management Of Janu Sandhigata vata Vis-a-Vis Osteoarthritis Of Knee Joint 
Scientific Title of Study   Clinical Study To Compare The Effect Of Salvana Upanaha Sweda And Shadanga Guggulu With Bala Ashwagandhadi Taila Janu Veshtana And Shadanga Guggulu In The Management Of Janu Sandhigata vata Vis-a-Vis Osteoarthritis Of Knee Joint 
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 Bhagyashree Kamate 
Designation  PG Scholar 
Affiliation  SKAMCH RC Bengaluru 
Address  First year PG scholar Kayachikitsa Department Room No 2 Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bengaluru
First year PG scholar Kayachikitsa Department Room No 2 Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bengaluru
Bangalore
KARNATAKA
560104
India 
Phone  9482676999  
Fax    
Email  bhagyashreekamate10@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr C V Rajashekhar 
Designation  MD Ayu 
Affiliation  SKAMCH RC Bengaluru 
Address  HOD Professor Kayachikitsa Department Room No 2 Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bengaluru
HOD Proffesor Kayachikitsa Department Room No 2 Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bengaluru
Bangalore
KARNATAKA
560104
India 
Phone  8867212844  
Fax    
Email  drrajhere@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr C V Rajashekhar 
Designation  MD AYU 
Affiliation  SKAMCH RC Bengaluru 
Address  HOD Professor Kayachikitsa Department Room No 2 Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bengaluru
HOD Proffesor Kayachikitsa Department Room No 2 Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bengaluru
Bangalore
KARNATAKA
560104
India 
Phone  8867212844  
Fax    
Email  drrajhere@yahoo.co.in  
 
Source of Monetary or Material Support  
Self Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bengaluru  
 
Primary Sponsor  
Name  Dr Bhagyashree Kamate 
Address  Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bengaluru  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 Kiran M Goud  SKAMCH RC Bengaluru  Professor Kayachikitsa Department Room No 2 Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bengaluru
Bangalore
KARNATAKA 		 9845109556

kiranmgoud@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SKAMCH RC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-VESHTANA (Procedure Reference: ASHTANAGA HRUDAYA, Procedure details: JANU VESHTANA PROCEDURE • Janu Veshtana will be done for first 7 consecutive days. • The affected knee joint of the subject will be exposed in sitting posture with extending legs on droni. • Mridu Abhyanga with Bala ashwagandhadi taila will be done followed by bandaging with cora cloth soaked in Bala Ashwagandhadi tail and kept for 6 hours. )
(1) Medicine Name: SHADANGA GUGGULU, Reference: RASARATNA SAMUCHAYA, Route: Oral, Dosage Form: Guggulu, Dose: 1(g), Frequency: tds, Duration: 15 Days
2Comparator ArmProcedure-upanAhasvedaH (sAgniH, उपनाहस्वेदः (साग्निः) (Procedure Reference: ASHTANGA HRUDAYA, Procedure details: SALVANA UPANAHA SWEDA PROCEDURE: •Salvana Upanaha Sweda for first 7 consecutive days. •Salvana upanaha will be performed by applying the thick paste of upanaha all over the affected knee joint region in the consistency of 1 cm thickness and the applied part will be wrapped with Eranda patra. Over this, bandaging will be done and ask the patient to retain the same for 12 hours. )
(1) Medicine Name: SHADANGA GUGGULU, Reference: RASARATNA SAMUCHAYA, Route: Oral, Dosage Form: Guggulu, Dose: 1(g), Frequency: tds, Duration: 15 Days
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with clinical features of janu sandhigata vata
Patients with the clinical features of Osteoarthritis Knee joint
Patients belonging to the age group of 40 - 60yrs irrespective of gender
Post covid and non covid patients

 
 
ExclusionCriteria 
Details  Post-surgical and prosthetic knee joints
Subjects with history of recent trauma and fracture
Subjects suffering from any other systemic disorders which interfere with the course of intervention

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
SALVANA UPANAHA SWEDA AND JANU VESHTANA ALONG WITH SHADANGA GUGGULU EFFECTIVE IN THE MANAGEMENT OF JANU SANDHIGATAVATA VIS A VIS OSTEOARTHRITIS KNEE JOINT  2weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NILL  NA 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   10/06/2022 
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="5" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Osteoarthritis is the second most common rheumatological problem and it is the most frequent joint disease with a prevalence of 22% to 39% in India. Sandhigata vata is mentioned in the context of Gatavata in charaka samhita. It is characterised by clinical features like Janu sandhi Shoola(Pain), Janu sandhi Atopa(crepitus), Vatapoornadruthi Sparsha(palpable like air filled bag), Janu sandhi Shotha(swelling), Akunchana prasarana vedana(pain during movements). Salvana Upanaha is a form of sweda also called as poultice, which includes vataharadravyas,amla,snigdha and gandhapradhana dravyas. Veshtana as a treatment modality in Vatasyopakrama and in chikitsasthana Vatavyadhi Adhyaya under snayu, sandhi, siragata vata chikitsa, veshtana is mentioned. which can be adopted here as a treatment  modality. Bala Ashwagandhadi taila used for Veshtana mentioned in Sahasrayogam, having Balya,Bramhana and Rasayana properties.Shadanga guggulu which is mentioned in Rasa Ratna samuchaya vatavyadhi chikitsa. Hence the present study is designed to evaluate the effect of Upanaha and Veshtana followed by Shadanga Guggulu in sandhigatavata vis-à-vis Osteoarthritis knee joint. Salvana Upanaha for 7 days with Shadanga Guggulu in 1 group, Bala ashwagandhadi Janu Veshtana for 7 days with Shadanga Guggulu in 2nd group.Osteoarthritis is the second most common rheumatological problem and it is the most frequent joint disease with a prevalence of 22% to 39% in India. Sandhigata vata is mentioned in the context of Gatavata in charaka samhita. It is characterised by clinical features like Janu sandhi Shoola(Pain), Janu sandhi Atopa(crepitus), Vatapoornadruthi Sparsha(palpable like air filled bag), Janu sandhi Shotha(swelling), Akunchana prasarana vedana(pain during movements). Salvana Upanaha is a form of sweda also called as poultice, which includes vataharadravyas,amla,snigdha and gandhapradhana dravyas. Veshtana as a treatment modality in Vatasyopakrama and in chikitsasthana Vatavyadhi Adhyaya under snayu, sandhi, siragata vata chikitsa, veshtana is mentioned. which can be adopted here as a treatment  modality. Bala Ashwagandhadi taila used for Veshtana mentioned in Sahasrayogam, having Balya,Bramhana and Rasayana properties.Shadanga guggulu which is mentioned in Rasa Ratna samuchaya vatavyadhi chikitsa. Hence the present study is designed to evaluate the effect of Upanaha and Veshtana followed by Shadanga Guggulu in sandhigatavata vis-à-vis Osteoarthritis knee joint. Salvana Upanaha for 7 days with Shadanga Guggulu in 1 group, Bala ashwagandhadi Janu Veshtana for 7 days with Shadanga Guggulu in 2nd group.

 
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