| CTRI Number |
CTRI/2019/07/020303 [Registered on: 22/07/2019] Trial Registered Prospectively |
| Last Modified On: |
19/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
treatment for the management of knee osteoarthritis. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of janubasti and janupichu with panchamula taila in janu sandhigat vata. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Choyal |
| Designation |
2yr MD Scholar |
| Affiliation |
parul institute of ayurveda |
| Address |
Parul institute of ayurveda, department of panchakarma, OPD no. 113, parul university, waghodia, vadodara, gujarat
Parul institute of ayurveda, department of panchakarma, OPD no. 113, parul university, waghodia, vadodara, gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
7869869888 |
| Fax |
|
| Email |
Ashishchoyal123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K B Roy |
| Designation |
Professor |
| Affiliation |
parul institute of ayurveda |
| Address |
Parul institute of ayurveda, parul university, limda, waghodia, vadodara, gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9825912141 |
| Fax |
|
| Email |
dr_kbroy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashish Choyal |
| Designation |
2yr MD Scholar |
| Affiliation |
parul institute of ayurveda |
| Address |
Parul institute of ayurveda, department of panchakarma, OPD no. 113, parul university, waghodia, vadodara, gujarat
Parul institute of ayurveda, department of panchakarma, OPD no. 113, parul university, waghodia, vadodara, gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
7869869888 |
| Fax |
|
| Email |
Ashishchoyal123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ashish ChoyalParul institute of ayurveda, parul university, waghodia, vadodara, gujarat, 391760
|
|
|
Primary Sponsor
|
| Name |
Ashish Choyal |
| Address |
Parul institute of ayurveda, parul university, waghodia, vadodara, gujarat, 391760 |
| Type of Sponsor |
Other [individual] |
|
|
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 |
| Asigh choyal |
parul Ayurveda Hospital |
Parul institute of ayurveda, department of panchakarma, OPD no. 113, parul university, waghodia, vadodara, gujarat 391760
Vadodara
GUJARAT |
7869869888
Ashishchoyal123@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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
janu basti and janu pichu with panchamoola taila |
two groups each of 15 patients with be randomly selected and intervend with janu basti and janu pichu with panchamoola taila.
dose - as required
frequency - once daily
route of administration in both the group is external application of oil and tampon respectively in each group.
study duration will be for 21 days |
| Comparator Agent |
not aplicable |
not aplicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
presenting with clinical symptoms of janusandhigat vata
acute osteoarthritis
who are fit for snehana and swedana |
|
| ExclusionCriteria |
| Details |
suffering from secondary and systemetic disorders.
joint disorders like rheumatoid arthritis, psoriatic arthritis, gouty arthritis.
anatomical deformity of joints by bith.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| cases randomly selected between 30 - 70 yr |
marked relief can be seen after 21 days of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| all cases prevalence at 50-70 yrs |
chief complaints may releived by 2 months with repeated followup |
|
|
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)
|
01/08/2019 |
| 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 any |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
two randomized groups consisting of 15 patients in each group will be made and comparitive study between janu basti and janu pichu with panchamoola taila will be conducted for 21 days and follow up will be taken. suitable statistical test will be applied to know the final overall result. the main purpose of this comparitive study is to analyse best mode of treatment for janusandhigata vata.
|