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CTRI Number  CTRI/2022/09/045250 [Registered on: 06/09/2022] Trial Registered Prospectively
Last Modified On: 01/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Study conducted to see the effect of swyambhuva guggulu vati and vatari taila in knee osteoarthritis.  
Scientific Title of Study   A Clinical study to evaluate the combined effect of Swyambhuva Guggulu Vati and Vatari Taila Janu Basti in Janusandhigata Vata with special reference to Knee Osteoarthritis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashwini Byali 
Designation  MD Scholar Kayachikitsa 
Affiliation  BVVS Ayurveda Medical College and Hospital BVVS Campus Bagalkot 
Address  Department of PG studies in Kayachikitsa BVVS Ayurveda Medical College and Hospital BVVS Campus Bagalkot

Bagalkot
KARNATAKA
587101
India 
Phone  9902486104  
Fax    
Email  ashwinibyali660@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sunilkumar M Chabanur 
Designation  Professor 
Affiliation  BVVS Ayurveda Medical College and Hospital,Bagalkot, karnataka 
Address  Department of PG Studies in Kayachikitsa BVVS Ayurveda Medical College and Hospital BVVS Campus Bagalkot

Bagalkot
KARNATAKA
587101
India 
Phone  9740878703  
Fax    
Email  drsunilkumar09@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR M M Salimath 
Designation  Principal and Professor 
Affiliation  BVVS Ayurveda Medical College and Hospital,Bagalkot, karnataka 
Address  Department of PG Studies in Shalyatantra BVVS Ayurveda Medical College and Hospital BVVS Campus Bagalkot

Bagalkot
KARNATAKA
587101
India 
Phone  9845010950  
Fax    
Email  dr_mahantesh@yahoo.com  
 
Source of Monetary or Material Support  
BVVS Ayurveda Medical College and Hospital,Bagalkot, Karnataka 
 
Primary Sponsor  
Name  BVVS Ayurved Medical College and Hospital 
Address  BVVS Ayurved Medical College and Hospital Bagalkot 
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 Ashwini Byali  Department of PG Studies in Kayachikitsa BVVS Ayurveda Medical College and Hospital   OPD andIPD Department of PG Studies in Kayachikitsa Department of PG Studies in Kayachikitsa BVVS Ayurveda Medical College and Hospital B Bagalkot
Bagalkot
KARNATAKA 		 9902486104

ashwinibyali660@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC BVVS AYURVEDA MEDICAL COLLEGE AND HOSPITAL BAGALKOT-587101  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Swyambhuva guggulu, Reference: vangasena, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: sukoshna jala), Additional Information: -
2Intervention ArmProcedure-jAnu-bastiH, जानु-बस्तिः (Procedure Reference: principles of panchakarma, Procedure details: A basti is constructed with dough masha on janusandhi with warm vatari taila is poured into it .when temperature comes down the oil is replaced with heated oil.this is done for 45 min in day.)
(1) Medicine Name: vatari taila, Reference: gadanigraha(taila prakarnam), Route: Topical, Dosage Form: Taila, Dose: 1000(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1)Diagnosed patients of Janusandhigata vata (Knee Osteoarthritis).
2)Patients with the age group between 40 to 70 years of either sex will be selected.
 
 
ExclusionCriteria 
Details  1) Patients with Vatarakta, Amavata, Kroshtukashirsha etc.
2) Patients having traumatic, neoplastic and infections of knee joints.
3) Patients with other systemic diseases which interferes with treatment.
4) Pregnant and lactating women.
5) Osteoarthritis with structural deformity – genu varum, genu vulgum.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To check the effect of swyambhuva guggulu vati and vatari taila in janusandhigata vata with special reference to knee osteoarthritis  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Swyambhuvaguggulu Vati and Vatari Taila in Janusandhigata vata with special reference to Knee Osteoarthritis.  30 days 
 
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   N/A 
Date of First Enrollment (India)   11/09/2022 
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="0" 
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  

                     Janusandhigata vata is described under Vatavyadhi in all Samhitas. Vata is prime factor among all Tridosha and is responsible for all activities and manifestation of diseases in body. If Vata lodges in Janusandhi it can leads to manifestation of Lakshana like, Shotha, Prasarana, Akunchana, Savedana, Sandhi-Stabdhata and Sandhi Atopa.

                      This can be correlated to Knee osteoarthritis. Osteoarthritis is degenerative disease that involves peripheral joints in which there is damage to cartilage and as well as overgrowth of bone.  

 Knee Osteoarthritis is leading cause of chronic disability in developed countries; some 1,00,000 people in the United States are unable to walk independently from bed to bathroom because of osteoarthritis of the knee.3 Prevalence rate of knee osteoarthritis is 10%. Currently India has prevalence rate of 22% to 39% osteoarthritis which is diagnosed only by symptomatic cause and knee Osteoarthritis is 5.8%.

        In contemporary science the management of knee osteoarthritis involves use of non-steroidal anti-inflammatory drugs, opiod analgesics and surgical interventions for control of symptoms.

                      All Brihatrayi and Laghutrayi mentioned Snehana treatment (Bahya & Abhyatara) as line of treatment in Janusandhigata vata. â€œSvayambhuva Guggulu Vati” which contains Guggulu as main ingredient which does the Vedanasthapana and contains drugs like Vyosha, Chitrika, etc. which are having Tikta, Kashaya, Katu, rasa and Ushna Veerya which does Vatashamaka. Janu Basti is a kind of Snigdhasweda, Samshamaniya, type of Bahirparimarjana Chikitsa. Vatari Taila which contains Tila Taila and Eranda does the Snehana there by Vatahara and due to Ushnata Swedana also takes place.  â€œHence the present study is taken to evaluate the combined effect of Swyambhuva Guggulu Vati and Vatari Taila Janu Basti in janusandhigata vata with special reference to Knee Osteoarthritis”.

 

 
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