| CTRI Number |
CTRI/2020/05/025174 [Registered on: 14/05/2020] Trial Registered Prospectively |
| Last Modified On: |
02/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect of Rasnadi Churna and Chaturbija Churna in the management of knee joint pain (Osteoarthritis). |
|
Scientific Title of Study
|
A clinico-comparative study of Rasnadi Churna and Chaturbija Churna in the management of Janusandhigata Vata |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Daya M Kalsariya |
| Designation |
PG Scholar |
| Affiliation |
Gujarat Ayurved University, Jamnagar |
| Address |
OPD No.9, Department of Kayachikitsa, Government Akhandanand Ayurved Mahavidhyalaya, Bhadra, Ahmedabad Gujarat
Ahmedabad Gujarat 380001 INDIA
Ahmedabad GUJARAT
380001
India
Ahmadabad
GUJARAT
380001
India |
| Phone |
7874815231 |
| Fax |
|
| Email |
dayaahir2203@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surendra A Soni |
| Designation |
HOD Professor |
| Affiliation |
Gujarat Ayurved University, Jamnagar |
| Address |
OPD No. 9, Department of Kayachikitsa,
Government Akhandanand Ayurved Mahavidhyalaya, Bhadra, Ahmedabad, Gujarat.
Ahmedabad Gujarat 380001 INDIA
Ahmedabad
GUJARAT
380001
India
Ahmadabad
GUJARAT
380001
India |
| Phone |
9808441150 |
| Fax |
|
| Email |
surendraasoni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surendra A Soni |
| Designation |
HOD Professor |
| Affiliation |
Gujarat Ayurved University, Jamnagar |
| Address |
OPD No. 9 Government Akhandanand Ayurved Mahavidhyalaya Bhadra Ahmedabad Gujarat
Ahmedabad Gujarat 380001 INDIA
Ahmedabad
GUJARAT
380001
India
Ahmadabad
GUJARAT
380001
India |
| Phone |
9808441150 |
| Fax |
|
| Email |
surendraasoni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Akhandanand Ayurved Mahavidhyalaya, Bhadra, Ahmedabad. |
|
|
Primary Sponsor
|
| Name |
Government Akhandanand Ayurved Mahavidhyalaya Bhadra Ahmedabad |
| Address |
OPD No. 9, Department of Kayachikitsa, Government Akhandanand ayurved Mahavidhyalay, Bhadra, Ahmedabad, Gujarat. Ahmedabad Gujarat 380001 INDIA |
| 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 |
| Daya M Kalsariya |
Government Akhandanand Ayurved Mahavidhyalaya, Ahmedabad |
OPD No. 9,Department of Kayachikitsa, Government Akhandanand Ayurved Mahavidhyalaya, Bhadra, Ahmedabad, Gujarat 380001 INDIA
Ahmadabad
GUJARAT |
7874815231
dayaahir2203@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Internal administration of Rasnadi Churna and Chaturbija Churna |
There are two groups in the study. One group of 15 patients is given internal administration of Rasnadi Churna 6 gm divided doses per day (3gm - BD), empty stomach for 4 weeks orally and another group of 15 patients is given internal administration of Chaturbija Churna 10 gms with divided doses per day (5gm - BD), empty stomach with Ushnodaka for 4 weeks orally. Pathya-Apathya is followed as per Vatavyadhi Chikitsa. |
| Comparator Agent |
Internal administration of Rasnadi Churna and Chaturbija Churna |
there are two groups in the study. one group of 15 patients is given internal administration of Rasnadi Churna 6 gm divided doses per day (3gm - BD), empty stomach for 4 weeks orally and another group of 15 patients is given internal administration of Chaturbija Churna 10 gms with divided doses per day (5gm -BD), empty stomach with Ushnodaka for 4 weeks orally. Pathya-Apathya is followed as per Vatavyadhi Chikitsa |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Chronicity up to 5 years.
Traumatic arthritis.
Patients having sign and symptoms of Janusandhigata Vata with fulfilling the diagnostic criteria. |
|
| ExclusionCriteria |
| Details |
Age below 30 years and above 70 years.
Patient suffering from Vatarkta, Amavata, systemic lupus erythmetus(SLE), Psoriatic arthritis,infective arthritis and other systemic serious disorders will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Result will be assessed on the basis of relief signs and symptoms of Janusandhigata vata |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| By comparing the effect of both drugs in the management of Janusandhigata Vata |
4 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
17/05/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To study the clinico-comparative effect of Rasnadi Churna and Chaturbija Churna in themanagement of Janusandhigata Vata. |