| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Comparator Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (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 | | 3 | Comparator Arm | Procedure | - | jAnu-bastiH, जानà¥-बसà¥à¤¤à¤¿à¤ƒ | (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 Mardana. Astimajjagatavata 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. |