| CTRI Number |
CTRI/2022/12/048072 [Registered on: 13/12/2022] Trial Registered Prospectively |
| Last Modified On: |
05/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Management ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinico-Comparative Study Of Rasnashirishadi Kwatha And Ajamodadi Vati On Sandhivata(Degeneration Of Joint Cartilage and the underlying Bone)WSR To Osteoarthritis Of Knee Joint |
|
Scientific Title of Study
|
A Clinico-Comparative Study Of Rasnashirishadi Kwatha And Ajamodadi Vati On Sandhivata WSR To Osteoarthritis Of Knee Joint |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NIMINA NANU MANIKKOTH |
| Designation |
Post Graduation Scholar |
| Affiliation |
Govt.Dhanwantari Ayurvedic Medical College and Hospital |
| Address |
Govt.Dhanwantari Ayurvedic Medical College and Hospital
Kayachikitsa Department opd no:18
Ujjain
456006
India
Govt.Dhanwantari Ayurvedic Medical College and Hospital
Kayachikitsa Department opd no:18
Ujjain
456006
India
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
9961977806 |
| Fax |
|
| Email |
nim3192@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr O P VYAS |
| Designation |
Professor and HOD |
| Affiliation |
Govt Dhanwantari Ayurvedic Medical College and Hospital |
| Address |
2nd floor.Department Of Kayachikitsa
Govt.Dhanwantari Ayurvedic College
Madhyapradesh
456006
India
2nd floor.Department Of Kayachikitsa
Govt.Dhanwantari Ayurvedic College
Madhyapradesh
456006
India
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
9713574071 |
| Fax |
|
| Email |
opvyas24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr O P VYAS |
| Designation |
Professor and HOD |
| Affiliation |
Govt Dhanwantari Ayurvedic Medical College and Hospital |
| Address |
2nd floor.Department Of Kayachikitsa
Govt.Dhanwantari AyurvedicCollege Ujjain
India
2nd floor.Department Of Kayachikitsa
Govt.Dhanwantari AyurvedicCollege Ujjain
Madhyapradesh
India
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
9713574071 |
| Fax |
|
| Email |
opvyas24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt.Autonomous Dhanwantari Ayurvedic College and Hospital Ujjain |
|
|
Primary Sponsor
|
| Name |
Govt.Dhanwantari Ayurvedic College and Hospital Ujjain |
| Address |
Mangalnath road Ujjain Madhyapradesh |
| Type of Sponsor |
Government medical college |
|
|
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 OP Vyas |
Govt Dhanwantari Ayurvedic Hospital |
Opd no18 Kayachikitsa Department
Govt Dhanwantari Ayurvedic Hospital
Ujjain
Madhyapradesh
Ujjain
MADHYA PRADESH |
9713574071
opvyas24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Govt Dhanwanatari Ayurvedic Hospital |
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: Rasnashirishadi Kwatha, Reference: Charaka Samhitha, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ajamodadi Vati, Reference: Yogaratnakara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -sukhoshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with classical signs and symptoms of Sandhivata
2)Patient between the age 40 years to 65 years of age |
|
| ExclusionCriteria |
| Details |
1)Patient below 40 years and above 65 years
2)Patients of Amavata,Vataraktha,and Diabetis
3)Associated with other systemic or metabolic disorder
4)Patients on steroid therapy
5)Associate with simple or compound fractures
6)Associated with trauma
7)Patients who have undergone surgery
8)Pregnant and lactating mother |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the intensity of classical signs and symptoms of Sandhivata like pain oedema etc |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effective management of Sandhivata by relieving the symptoms like pain oedema etc and improve the physical functions of patient |
After 2 months of study |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/12/2022 |
| 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
|
Not yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Randomized interventional study of Rasnashirishadi Kwatha and ajamodadi vati on Sandhivata WSR to Osteoarthritis of knee joint..Total 60 patients will be enrolled in the present study.selected patients will be divided in to three groups on the basis of computer generated randomisation.Group A containing 20 patients will be given Rasnashirishadi Kwatha.Group B containing 20 patients will be given Ajamodadi vati,and in the third group containing 20 patients will be given with both Rasnashirishadi Kwatha and Ajamodadi Vati…..Follow up will be on every 10 th day. |