| CTRI Number |
CTRI/2025/02/081199 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare effectiveness of Janu Basti and Ultrasound therapy in Knee joint Osteo arthritis |
|
Scientific Title of Study
|
A Randomised Open Labelled Comparative Clinical STudy to Evaluate the Efficacy of Janu Basti with Mahanarayana Taila in Comparison to Ultrasound Therapy 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 |
DrDivyani P Das |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of PG Studies in Panchakarma
Sri Sri College of Ayurvedic Science and Research
21st KM, Kanakapura Road,
Udayapura
Bengaluru
Bangalore KARNATAKA 560082 India |
| Phone |
9148096726 |
| Fax |
|
| Email |
divyanipdas@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ganesh Puttur |
| Designation |
Professor and HOD |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of PG Studies in Panchakarma
Sri Sri College of Ayurvedic Science and Research
21st KM, Kanakapura Road,
Udayapura
Bengaluru
Bangalore KARNATAKA 560082 India |
| Phone |
9448176059 |
| Fax |
|
| Email |
drganeshputtur@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrDivyani P Das |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of PG Studies in Panchakarma
Sri Sri College of Ayurvedic Science and Research
21st KM, Kanakapura Road,
Udayapura
Bengaluru
Bangalore KARNATAKA 560082 India |
| Phone |
9148096726 |
| Fax |
|
| Email |
divyanipdas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Divyani P Das
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore
Karnataka
India
Pin: 560082 |
|
|
Primary Sponsor
|
| Name |
Divyani P Das |
| Address |
Department of PG Studies in Panchakarma
Sri Sri College of Ayurvedic Science and Research
21st KM, Kanakapura Road,
Udayapura
Bengaluru
Karnataka
India
Pin: 560082 |
| 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 Divyani P Das |
Sri Sri College of Ayurvedic Science and Reasearch Hospital |
Room No: 8
Panchakarma Department
Sri Sri College of Ayurvedic Science and Reasearch Hospital
Udayapura
Kanakapura Road
Bengaluru Bangalore KARNATAKA |
9148096726
divyanipdas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | jAnu-bastiH, जानु-बस्तिः | (Procedure Reference: Acharya GS. Panchakarma Illustrated. 1st ed. Varanasi: Chaukhambha Orientalia; 2006. p. 261, Procedure details: Poorvakarma - Mashapali is applied. Pradhanakarma - Indirectly heated mahanarayana taila is retained for 30 minutes. Paschatkarma - taila & Pali removed followed by mridu Abhyanga) (1) Medicine Name: Mahanarayana Taila, Reference: Mahanarayana Taila, Reference: Ayurvedic Formulary of India. Part 1. 2nd ed. New Delhi: Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homoeopathy (AYUSH); [Year of publication]. p. 149-150, Route: Topical, Dosage Form: Taila, Dose: 800(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Ultrasound Therapy | Ultrasound gel is applied & therapy is done with ultrasound probe continuously moving in circular motions for 15 minutes for each knee joint |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects between the age group of 21 to 60 years irrespective of gender, religion, occupation, and socioeconomic status.
Subjects presenting with Pratyatma Lakshanas of Janu Sandhigatavata.
Subjects fit for Janu Basti and Ultrasound therapy.
Subjects who are willing to give a written consent for the treatment.
Obesity and diabetes mellitus patients under medications can be included in the study, provided it is controlled. |
|
| ExclusionCriteria |
| Details |
Subjects below 21 years and above 60 years of age.
Subjects unfit for Janu Basti and Ultrasound therapy, including those with skin lesions, cuts, wounds, rashes, or skin diseases.
Conditions associated with fractures and other systemic illnesses that interfere with the treatment protocol.
Subjects with skin diseases and open lesions on knee joints.
Subjects with an established diagnosis of Gouty arthritis and Rheumatoid arthritis.
Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
•To evaluate the efficacy of Janu Basti with Mahanarayana Taila in Janu Sandhigatavata on the basis of changes noted in total score in important subjective parameters in the institute’s clinical set up.
•To evaluate the efficacy of ultrasound therapy in Janu Sandhigatavata on the basis of changes noted in total score in important subjective parameters in the institute’s clinical set up.
•To compare the efficacy of Janu Basti with Mahanarayana Taila and ultrasound therapy in Janu Sandhigatavata.
|
1st day: Before commencement of treatment.
8th day: After completion of the treatment.
15th day: 7 days after completion of the treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| |
|
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
10/03/2025 |
| 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 Yet Recruiting |
| 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 compared with osteoarthritis in contemporary medical science due to the similarities in their symptoms. Janu Sandhigatavata is characterized by symptoms such as pain, stiffness, swelling, crepitus, and reduced range of motion in the knee joint. These symptoms are believed to arise due to an imbalance of Vata Dosha, leading to the accumulation of Ama and the deterioration of cartilage and synovial fluid in the knee joint The procedures like, Snehana, Swedana, Lepa, Upanaha, Agnikarma are indicated in the cure of Sandhigatavata .Swedana is one of the important Upakrama mentioned for Vata Dosha. As Pradhana Karma, Swedana can be adopted according to the disease condition. • Ultrasound therapy is used as a complementary treatment in physical therapy regimens focused on managing pain and aiding in the healing of soft tissue injuries. The treatment exerts therapeutic effects through thermal (continuous UST) and non-thermal (pulsed UST) modalities. Continuous UST achieves the thermal effect and is purposed to produce analgesia through temperature elevation, which increases capillary permeability and tissue metabolism, thereby enhancing fibrous tissue extensibility and pain thresholds. Non-thermal effects are achieved by modulating cell membrane permeability, increasing protein synthesis, and activating immune response near the injury site, which may stimulate regeneration of damaged tissue. Hence for an effective solution, an attempt is made to evaluate and compare Janu Basti with Mahanarayana Taila and ultrasound therapy in the management of Janu Sandhigatavata. |