| CTRI Number |
CTRI/2017/12/010883 [Registered on: 14/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
12/12/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on sandhigata vata with matrabasti and shaman drug. |
|
Scientific Title of Study
|
A clinico comparative study on the efficacy of sahacharadi kwath with and without matra basti in the managment of janu sandhigat vata w.s.r. to osteo arthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hetal Ramani |
| Designation |
Pg scholor |
| Affiliation |
govt,akhandanand ayurvedic college,bhadra,ahmedabad |
| Address |
Room no 11,panchkarma department,govt akhandanand ayurved college and hospital, bhadra,ahmedabad
Ahmadabad
GUJARAT
380006
India |
| Phone |
9409526369 |
| Fax |
|
| Email |
hetalramani78@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sweety Ruparel |
| Designation |
HOD of Panchkarma Department |
| Affiliation |
govt,akhandanand ayurvedic college,bhadra,ahmedabad |
| Address |
Room no 11,panchkarma department,govt akhandanand ayurved college and hospital, bhadra,ahmedabad
Ahmadabad
GUJARAT
380006
India |
| Phone |
9409526369 |
| Fax |
|
| Email |
sweetyruparel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hetal Ramani |
| Designation |
Pg scholor |
| Affiliation |
govt,akhandanand ayurvedic college,bhadra,ahmedabad |
| Address |
Room no 11,panchkarma department,govt akhandanand ayurved college and hospital, bhadra,ahmedabad
Ahmadabad
GUJARAT
380006
India |
| Phone |
9409526369 |
| Fax |
|
| Email |
hetalramani78@gmail.com |
|
|
Source of Monetary or Material Support
|
| gujarat ayurved university,jamnagar |
|
|
Primary Sponsor
|
| Name |
Govt Akhandanand Ayurved College and Hospital Bhadra |
| Address |
Room no. 11 OPD of Panchkarma Department Govt Akhandanand
Ayurved College and Hospital Bhadra Ahmedabad |
| 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 Hetal Ramani |
Govt Akhandanand Ayurved College and Hospital |
Room no 11 Department ofPanchkarma GovtAkhandanand Ayurved College and Hospital,
Bhadra ,Ahmedabad
Ahmadabad
GUJARAT |
9409526369
hetalramani78@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 |
janu sandhigatavata, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A clinico comparative study on the efficacy of sahacharadi kwath with and without matra basti in the managment of janu sandhigat vata w.s.r. to osteo arthritis |
15 patients will be treated with Matra Basti of Sahachar Tail for 15 consecutive days. Simultaneously patients will also be given Sahacharadi Kwath orally for 4 weeks |
| Comparator Agent |
sahacharadi kwath |
A clinico comparative study on the efficacy of sahacharadi kwath with and without matra basti in the managment of janu sandhigat vata w.s.r. to osteo arthritis |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Matra Basti Yogya
2)Patients presenting with the classical signs and symptoms of Sandhi Vata (OA) like Sandhishula, Sandhishotha, Akunchan prasarne vedana
3)Patients of either sex age between 40 – 70 years will be included.
|
|
| ExclusionCriteria |
| Details |
Matra Basti Ayogya.
Patients below 40 years and above 70 years of age.
Patients suffering from Vatarakta, Amavata, Systemic Lupus Erythematous (SLE), Bone TB, diabetes, Psoriatic arthritis and other serious systemic disorders will be excluded.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Find Improvement in signs and symptoms of Janu sandhigata vata with the help of scoring pattern. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in symptoms of Janu sandhigata 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)
|
27/05/2017 |
| 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) |
Open to Recruitment |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is randomized parallel group trial in department of Panchkarma OPD at govt. akhandanand Ayurvedic college and hospital.Matra basti will be given as per classical texts and s.o.p.simunteneosly sahacharadi kwath will also be given with matra basti and in another group only sahacharadi kwath will be given for 4 weeks.
|