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CTRI Number  CTRI/2024/08/072432 [Registered on: 13/08/2024] Trial Registered Prospectively
Last Modified On: 12/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic management of knee joint pain 
Scientific Title of Study   A Comparative Clinical Study to evaluate the efficacy of Mahasneha with Mahanarayana Taila as Matra Basti and Janu Basti in 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 PALLAVI N M 
Designation  PG Scholar 
Affiliation  Government Ayurveda Medical College and Hospital Mysore 
Address  Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital Mysore Vishweshwaraiah Circle Devaraj Mohalla Mysore Karnataka 570001 India

Mysore
KARNATAKA
570001
India 
Phone  8747028584  
Fax    
Email  pallavibilimagga@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SANJAY KUMAR M D 
Designation  Professor 
Affiliation  Government Ayurveda Medical College and Hospital Mysore 
Address  Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital Mysore Vishweshwaraiah Circle Devaraj Mohalla Mysore Karnataka 570001 India

Mysore
KARNATAKA
570001
India 
Phone  9986083244  
Fax    
Email  drsanjaygowda@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR PALLAVI N M 
Designation  PG Scholar 
Affiliation  Government Ayurveda Medical College and Hospital Mysore 
Address  Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital Mysore Vishweshwaraiah Circle Devaraj Mohalla Mysore Karnataka 570001 India

Mysore
KARNATAKA
570001
India 
Phone  8747028584  
Fax    
Email  pallavibilimagga@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College and Hospital Mysore Karnataka 570001 India  
 
Primary Sponsor  
Name  DR PALLAVI N M 
Address  Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital Mysore 
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 PALLAVI N M  Government Ayurveda Medical College and Hospital Mysore  Kayachikithsa OPD,Room number 10 and IP Wards of Government Ayurveda Medical College and Hospital Mysore Karnataka 570001 India.
Mysore
KARNATAKA 
8747028584

pallavibilimagga@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Ayurveda Medical College Mysore   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: Trayodashanga Guggulu, Reference: Bhaishajya Ratnavali Chapter 26, Route: Oral, Dosage Form: Guggulu , Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushnajala), Additional Information: -
2Comparator ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Charaka Samhita, Procedure details: Mahanarayanataila is administered via the rectal route)
(1) Medicine Name: Mahasneha, Reference: Ashtanga Hrudaya Chikitsa Sthana 26 , Route: Rectal, Dosage Form: Ghrita, Dose: 72(ml), Frequency: od, Duration: 8 Days
(2) Medicine Name: Mahanarayana Taila, Reference: Bhaishajya Ratnavali Chapter 26, Route: Rectal, Dosage Form: Ghrita, Dose: 72(ml), Frequency: od, Duration: 8 Days
3Comparator ArmProcedure-jAnu-bastiH, जानु-बस्तिः (Procedure Reference: Panchakarma illustrated by Dr G Shrinivasa Acharya, Procedure details: Mahasneha is made lukewarm and slowly poured into the ring constructed by black gram flour around the knee)
(1) Medicine Name: Mahasneha, Reference: Ashtanga Hrudaya Chikitsa Sthana, Route: Topical, Dosage Form: Ghrita, Dose: 200(ml), Frequency: od, Duration: 8 Days
(2) Medicine Name: Mahanarayana Taila, Reference: Bhaishajya Ratnavali 26, Route: Topical, Dosage Form: Taila, Dose: 200(ml), Frequency: od, Duration: 8 Days
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Subjects of all gender belonging to the age group of 40
to 70years with signs and symptoms of Janu Sandhigata Vata vis-a-vis osteoarthritis of knee joint will be selected for the study.
2. Both fresh and treated cases will be taken for the study.
Definition of fresh cases include freshly detected and untreated cases of Janu Sandhigata Vata vis-a-vis osteoarthritis of knee joint.
Definition of treated cases includes, already diagnosed and treated cases of Janu Sandhigata Vata vis-a-vis osteoarthritis of knee joint, who had voluntarily discontinued the treatment and will be included after a flush out period of 7 days. 
 
ExclusionCriteria 
Details  1.Subjects with grade 4(severe)osteoarthritis.
2.Subjects with complications or co-morbidities of OA, Osteonecrosis of the knee, Ruptured Baker cyst, Bursitis (knee) will be excluded.
3.Post surgical and Prosthetic knee joints will be excluded.
4.Subjects with history of acute trauma (less than 3 months) and fracture of knee joint will be excluded.
5.Subjects suffering from any other systemic disorders such as uncontrolled DM (RBS more than 250mg/dl) HbAlcmore than 9, and Hypertension (BP more than 160/100mmhg), renal disorder. which interfere with the course of treatment will be excluded.
6.Subjects with Obesity (grade II) BMI more than 35 will be excluded.
7.Subjects who are unfit for Matra basti procedure will be excluded. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessing relief in the symptoms of osteoarthritis of knee joint like swelling ,pain ,stiffnes ,crepitus .  At baseline ,9th day (mid assessment) and 39th day (post assessment). 
 
Secondary Outcome  
Outcome  TimePoints 
Compare the efficacy of Mahasneha with Mahanarayana taila as Matrabasti and Janubasti in Janu Sandhigata Vata in relieving the symptoms of Janu Sandhigata Vata through WOMAC Scale  38 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   Phase 3 
Date of First Enrollment (India)   20/08/2024 
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  

Sandhigatavata is one among Shoola and Shotha Pradhana Vata Vyadhi. It is mentioned in the context of Gatavata in the classical texts. The clinical features are swelling in the joints, and pain which increases on extension and flexion and there will be damage to the joint leading to functional impairment The clinical features of Sandhigatavata are similar to osteoarthritis. Osteoarthritis is an abnormality of the synovial joints, characterized by softening, splitting and fragmentation of articular cartilage not attributable to direct contact with inflammatory tissue. This is usually accompanied by subchondral sclerosis and bony cysts, joint space narrowing and bony overgrowths at tissue joint margins.Osteoarthritis is the most common type of arthritis ,commonly affected joints include knee, hip, first metatarsal phalangeal joint  and joints of cervical and lumbar spine. The overall prevalence of OA in India is 28.7-39 percentage  with female prevalence of 31.6 percentage .Symptomatic management in modern medicine is through NSAIDs, opioid analgesics and glucocorticoids. Long term usage of above medicines causes gastrointestinal, hepatic toxicity, renal impairment. And surgery is recommended only if patient have severe symptoms and it causes economic burden to the patients. Hence an alternative ,natural ,effective , safer management needs to be explored for this disorder. Management protocol for  Sandhigata Vata includes therapeutic methods like Snehana , Upanaha, Agnikarma , Bandhana and  MardanaAstimajjagatavata samprapti is also seen in Janusandhigata vata and Sandhi shoola is one of the symptom of Astimajjagatavata. hence the treatment protocol of Astimajjagatavata can be adopted in Sandhigatavata. Bahyabhyantara Sneha prayoga are proposed for Asthimajjagatavata  .Sneha Basti is one of the route of Abhyantara Sneha Prayoga and Basti is the best chikithsa for Vatavyadhi . Matrabasti is a type of Sneha Basti which is effective in Kevala Vata condition because of its Snehana, Brumhana properties.Matra basti is given in very smaller dosage and it can be administered at anytime,for longer duration without any complications. Parihara kala has not been addressed in relation to Matrabasti. Hence it is more feasible to the patients and can be given in OPD level. Bahya sneha is given in the form of Janubasti which is one of the effective Sthanika chikithsa for Janusandhigata vata. Mahasneha is a variety of Sneha Kalpana prepared by all four varieties of Sneha indicated in Astimajjagata vata,due to its Shreshta Vatahara properties.Mahanarayana taila is Vatahara Brumhana. Trayodashanga guggulu is indicated in Asti,Sandhi,Majja and Snayugata vata. Keeping above rationality into consideration Mahasneha and Mahanarayana taila are selected for Bahyabhyantara Snehana  as Matra basti and Janubasti.

 
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