| CTRI Number |
CTRI/2025/05/087631 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
16/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Janubasti with Herbal Oil and Interferential Therapy for Knee Joint Pain and Stiffness |
|
Scientific Title of Study
|
A Comparative Clinical Study To Study The Effect of Janubasti With Panchguna Taila And Interferential Therapy in Janusadhigata vata |
| 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 Unnati Devraj Gavale |
| Designation |
PG SCHOLAR |
| Affiliation |
Dhanwantari ayurved college hospital and research centre siddapur |
| Address |
Department Of PG Studies in Panchakarma
Dhanvantari Ayurved College Hospital and PG Research Centre Siddapur Uttara Kannada
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
9518785751 |
| Fax |
|
| Email |
gavaleunnati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRashmi Kalagi |
| Designation |
Associate Professor |
| Affiliation |
Dhanwantari ayurved college hospital and research centre siddapur |
| Address |
Department Of PG Studies in Panchakarma Dhanvantari Ayurved College Hospital and PG Research Centre Siddapur Uttara Kannada
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
8050475152 |
| Fax |
|
| Email |
drrashmivk88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Kalagi |
| Designation |
Associate Professor |
| Affiliation |
Dhanwantari ayurved college hospital and research centre siddapur |
| Address |
Department Of PG Studies in Panchakarma
Dhanvantari Ayurved College Hospital and PG Research Centre Siddapur Uttara Kannada
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
8050475152 |
| Fax |
|
| Email |
drrashmivk88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dhanwantari ayurved college hospital and research centre Siddapur Karnataka 581355 |
|
|
Primary Sponsor
|
| Name |
Dr Unnati Devraj Gavale |
| Address |
Department Of PG Studies in Panchakarma Dhanvantari Ayurved College Hospital and PG Research Centre Siddapur Uttara Kannada 581355
|
| 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 Unnati Gavale |
Dhanvantari Ayurved College Hospital and PG Research Centre |
Dhanvantari Ayurved College Hospital and PG Research Centre Siddapur Uttara Kannada
Uttara Kannada
KARNATAKA |
7887371804
gavaleunnati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dhanvantari Ayurveda College Hopsital and Research Center |
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 | Comparator Arm | Procedure | - | Interferential therapy | (Procedure Reference: CLAYTONS ELECTROTHERAPY, Procedure details: Interferential Therapy
4 electrodes are placed over the knee region
Intensity- According to patients tolerance
Mode- 4 pole per electrodes & frequency 0-140 mHz
Time of procedure- 8-10 minutes
Duration- 14 days)
| | 2 | Intervention Arm | Procedure | - | jAnu-bastiH, जानु-बस्तिः | (Procedure Reference: NYAY CHANDRIKA (SUSHRUT SAMHITA TIKA), Procedure details: Janu Basti
Dose- Quantity sufficient
Duration- 14 days)
(1) Medicine Name: PANCHAGUNA TAILA, Reference: NYAY CHANDRIKA, Route: Topical, Dosage Form: Taila, Dose: 200(ml), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient is fit for janubasti and interferential therapy.
2. Patient in age group from 40 to 60 years.
3. Patient having following symptoms such as- Pain, swelling, tenderness, crepitus, stiffness.
|
|
| ExclusionCriteria |
| Details |
1.Patient is not fit for janubasti and interferential therapy.
2.Patients of chronic Osteoarthritis of knee joint with bony deformity.
3. Patients suffering from Rheumatic Heart Disease, Gouty arthritis.
4. Patients with systemic disorders such as uncontrolled diabetes mellitus and hypertension.
5. Patient suffering from skin disease and open lesions.
6. Pregnant women
7. Patient suffering from osteopenia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Clinical symptoms and objective parameters such as Pain, Swelling, Tenderness, Crepitus , Degree of flexion in knee joint. |
Janubasti- 14 days
Interferential Therapy- 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate weather Panchaguna Taila is more effective than Interferential Therapy in managing the symptoms of Janusandhigata vata |
Janubasti- 14 days
Interferential Therapy- 14 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
Modification(s)
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/05/2025 |
| 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 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
|
A Comparative clinical study to study the effect of Janubasti with Panchaguna Taila (medicated oil with anti-inflammatory) and Interferential Therapy (physiotherapy modality using electrical stimulation) in managing Janusandhigata Vata (OsteoArthritis of knee joint). The study aims to assess and compare these treatment’s effect on symptoms like pain, swelling, tenderness, crepitus, and degree of flexion of Janusandhigata Vata. A total 40 patients divided into 2 groups will undergo these therapies. The methodology includes ethical approval , informed consent, subjective criteria, objective criteria (example- VAS Scale and RAI tenderness scale). The clinical trial likely highlight the holistic and deeper healing potential of Ayurvedic therapy and conventional therapy.
|