| CTRI Number |
CTRI/2025/02/081191 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
16/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Study the management of ayurvedic formulation in Janu Sandhigat Vata (Knee Osteoarthritis)
|
|
Scientific Title of Study
|
Evaluation of the efficacy of an ayurvedic formulation in Janu Sandhigat Vata( Knee Osteoarthritis)- A Clinical Study |
| 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 Khushang Vijay More |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Dr.D.Y.Patil college of Ayurved and research center |
| Address |
OPD no-5 Kayachikitsa Department, Dr.D.Y.Patil College of Ayurved and Research Center, Sant Tukaram Nagar, Pimpri Pune Maharashtra
411018
India
OPD no-5 Kayachikitsa Department, Dr.D.Y.Patil College of Ayurved and Research Center, Sant Tukaram Nagar, Pimpri Pune Maharashtra
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
7387334510 |
| Fax |
|
| Email |
khushangmore44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Digambar Dipankar |
| Designation |
MD Kayachikitsa |
| Affiliation |
Dr.D.Y.Patil college of Ayurved and research center |
| Address |
OPD no-5 Kayachikitsa Department, Dr.D.Y.Patil College of Ayurved and Research Center, Sant Tukaram Nagar, Pimpri Pune Maharashtra
411018
India
OPD no-5 Kayachikitsa Department, Dr.D.Y.Patil College of Ayurved and Research Center, Sant Tukaram Nagar, Pimpri Pune Maharashtra
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9822279321 |
| Fax |
|
| Email |
drdgdipankar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khushang Vijay More |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Dr.D.Y.Patil college of Ayurved and research center |
| Address |
OPD no-5 Kayachikitsa Department, Dr.D.Y.Patil College of Ayurved and Research Center, Sant Tukaram Nagar, Pimpri Pune Maharashtra
411018
India
OPD no-5 Kayachikitsa Department, Dr.D.Y.Patil College of Ayurved and Research Center, Sant Tukaram Nagar, Pimpri Pune Maharashtra
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
7387334510 |
| Fax |
|
| Email |
khushangmore44@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil college of Ayurved and research center Sant tukaram Nagar Pimpri Pune 411018
Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Khushang Vijay More |
| Address |
Dr.D.Y.Patil college of Ayurved and research center Sant tukaram
Nagar Pimpri Pune 411018 |
| 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 Khushang Vijay More |
Dr.D.Y.Patil college of Ayurved and research center Pimpri Pune |
OPD no -5 Kayachikitsa
Department
Dr.D.Y.Patil college of
Ayurved and research
center Pimpri Pune
411018 Maharashtra
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
7387334510
khushangmore44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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 | Drug | Classical | | (1) Medicine Name: Ayurvedic herbal formulation, Reference: Dhanwantri nighantu, charak sutrsthan,kaiyadev nighantu, bhavprakash chikitsasthan, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient within the age group of 40 to 70 years. 2.Patients fulfilling the criteria for diagnosis of Janu Sandhigat Vata such as Sandhishoola(joint pain), pain during akunchan(flexion) and Prasarana (extension) of joint and Vatpurndrutisparsha( feeling of joint like an inflated leather bag)
|
|
| ExclusionCriteria |
| Details |
1.Patients with known case of Musculoskeletal disorders like Amavata (Rheumatoid arthritis), gout.2.Patients with known case of Neurological disorders like Muscular dystrophy, Myasthenia gravis.3.Patients with a history of Tuberculosis, malignancy, trauma, cardiac diseases.4.Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in knee joint pain of Janusandhigat Vata using the VAS scale before and after treatment.
Improvement in range of motion- flexion of knee joint in Janusandhigat Vata from grade 2 to 1.
Improvement in walking time before and after treatment.
Improvement in knee joint swelling before and after the treatment.
Improvement in knee crepitation before and after the treatment.
|
28 days study with 2 follow ups(0,14,28) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in range of motion- flexion of knee joint in Janusandhigat Vata from grade 2 to 1.
Improvement in walking time before and after treatment.
Improvement in knee joint swelling before and after the treatment.
Improvement in knee crepitation before and after the treatment.
|
28 days study with 2 follow ups(0,14,28) |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| 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="6"
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
|
The aim is to study the effectiveness of Ayurvedic formulation in the management of Janu Sandhigat Vata (Knee Osteoarthritis) the study will be conducted with 45 patients showing signs and symptoms of Janu Sandhigat Vata, they will be administered with Ayurvedic formulation 2 tablets twice a day with lukewarm water for the duration conclusion will be drawn on the basis of proper statistical methods. |