| CTRI Number |
CTRI/2025/01/079722 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of knee osteo arthritis with the help of Ayurvedic medicine |
|
Scientific Title of Study
|
A CLINICO-COMPARATIVE STUDY OF ABHADI CURNA AND
ASVAGANDHAMULA CURNA PLUS ATIBALAMULA CURNA IN THE PATIENTS OF JANU SANDHIGATAVATA (KNEE OSTEO ARTHRITIS)
|
| 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 Pinaben V Dalshaniya |
| Designation |
PG Scholar |
| Affiliation |
J S Ayurveda Mahavidyalaya |
| Address |
Department of Kayachikitsa J S Ayurveda Mahavidyalaya and P D Patel Ayurved Hospital college road nadiad
Kheda
GUJARAT
387001
India
Kheda
GUJARAT
387001
India |
| Phone |
8469663860 |
| Fax |
|
| Email |
pinadalshaniyapatel123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Kalapi B Patel |
| Designation |
professor and HOD of Department of Panchakarma |
| Affiliation |
J.S.Ayurved Mahavidyalaya |
| Address |
Department of panchakarma J S Ayurveda Mahavidyalaya College road Nadiad
Kheda
GUJARAT
387001
India
Kheda
GUJARAT
387001
India |
| Phone |
9428661664 |
| Fax |
|
| Email |
drkalapi@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Kalapi B Patel |
| Designation |
professor and HOD of Department of Panchakarma |
| Affiliation |
J.S.Ayurved Mahavidyalaya |
| Address |
Department of panchakarma J S Ayurveda Mahavidyalaya College road Nadiad
Kheda
GUJARAT
387001
India
Kheda
GUJARAT
387001
India |
| Phone |
9428661664 |
| Fax |
|
| Email |
drkalapi@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Sundar Ayurveda Pharmacy J S Ayurveda Mahavidyalaya college road Nadiad
Dis Kheda
Gujarat
India
387001 |
|
|
Primary Sponsor
|
| Name |
J s ayurveda mahavidyalaya |
| Address |
college road Nadiad
Dis Kheda
Gujarat
India
387001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pinaben V Dalshaniya |
P D Patel ayurveda hospital, nadiad |
Department of Kayachikitsa OPD Room no 101 and 102 Nadiad 387001
Kheda
GUJARAT |
8469663860
pinadalshaniyapatel123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research |
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 | Drug | Other than Classical | | (1) Medicine Name: Ashwagandhamula churna plus atibalamula churna , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 03(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 04 Weeks, anupAna/sahapAna: Yes(details: Ushnodaka ), Additional Information: Preparation done according to API | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Abhadi churna , Reference: Yogaratnakar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 03(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 04 Weeks, anupAna/sahapAna: Yes(details: Ushnodaka ), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
•
Patients fulfilling the ayurvedic as well as modern criteria of diagnosis of jÄnu sandhigatavÄta (osteoarthritis of knee joint).
•
Patients with signs and symptoms of knee joint osteoarthritis.
•
Patients between age group of 40-80 years of both genders will be selected.
•
Patients with diabetes mellitus (PP2BS less than 300 mg per dl) and Hypertension(moderate) along with jÄnu sandhigatavÄta will also be included. |
|
| ExclusionCriteria |
| Details |
•
Female patients having pregnancy or lactating period.
•
Patient with associated disease which affects the outcomes or completion of the treatment i.e., osteoporosis, hyperthyroidism or hypothyroidism, cancer, tuberculosis, heart diseases, rheumatoid arthritis, psoriatic arthritis, kidney disorders and liver disorders.
•
Patient having past traumatic history and complete loss of articular cartilage.
•
Patients who have taken medication of corticosteroids within last 3 months and/or NSAIDs or any antibiotic medicines within last 7 days.
•
Patient who has history of previously joint replacement.
•
Patients with any previous anatomical deformity. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the effect of Abhadi churna in compare to Ashwagandhamula churna plus atibalamula churna by observing the changes in VAS and WOMAC SCALE before and after treatment in the patients of Janusandhigata vata |
2 weeks and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the effect of Abhadi churna in compare to Ashwagandhamula churna plus atibalamula churn by observing the changes in kellegren Lawrence system in the patients of janusandhigata vata (Knee osteoarthritis) |
4 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
03/02/2025 |
| 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
|
Sandhigatavata occurs when vitiated vata lodges in sandhi Caraka explained sandhigatavata with symptoms of sotha(swelling) vatapurna druti sparsha(on palpation revealed as air filled bag) and Akunchan Prasaranayo vedana(pain on flexion and extension of joints) Susruta also mentioned sula and sotha in this disease leading to the restricted movement of involved joint Madhav nidan adds Aatopa(crepitus on joints) On the basis of above characteristics Janusandhigata vata can be correlated with knee osteoarthritis (OA) OA is defined as chronic joint disorder with deterioration of articular cartilage and bone at joint margin called osteophytes and capsular fibrosis It can affect many joints but most commonly affects the knee, hip and spine. Registered patients will be randomized in two groups by using the block randomization methods and from them one group will be given Abhadi churna and another group will be given Ashwagandhamula churna plus atibalamula churna and the effect of these will be observed by recording changes in VAS and WOMAC SCALE and Kellgren Lawrence system after treatment
|