| CTRI Number |
CTRI/2018/05/013786 [Registered on: 09/05/2018] Trial Registered Prospectively |
| Last Modified On: |
09/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of anal administration of an ayurvedic preparation "Panchtiktaguggulu Ghrita" in Osteoarthritis. |
|
Scientific Title of Study
|
Study to evaluate the efficacy of Matra Vasti of Panchtiktaguggulu Ghrita in Sandhivata(Osteoarthritis) |
| Trial Acronym |
Sandhigata vata |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrNRSingh |
| Designation |
Prof.& HOD |
| Affiliation |
Ch.Brahm Prakash Ayurved Charak Sansthan,New Delhi |
| Address |
PG dept. of kaya chikitsa, Ch.Brahm Prakash Ayurved Charak Sansthan,Khera Dabar, Najafgarh, New Delhi 73.
Ch.Brahm Prakash Ayurved Charak Sansthan,Khera Dabar, Najafgarh, New Delhi 73.
New Delhi
DELHI
110073
India |
| Phone |
9560659728 |
| Fax |
|
| Email |
naimishraj@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNRSingh |
| Designation |
Prof.& HOD |
| Affiliation |
Ch.Brahm Prakash Ayurved Charak Sansthan,New Delhi |
| Address |
PG dept. of kaya chikitsa, Ch.Brahm Prakash Ayurved Charak Sansthan,Khera Dabar, Najafgarh, New Delhi 73.
Ch.Brahm Prakash Ayurved Charak Sansthan,Khera Dabar, Najafgarh, New Delhi 73.
New Delhi
DELHI
110073
India |
| Phone |
9560659728 |
| Fax |
|
| Email |
naimishraj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNeetu Sharma |
| Designation |
P.G.Scholar |
| Affiliation |
Ch.Brahm Prakash Ayurved Charak Sansthan,New Delhi |
| Address |
PG dept. of kaya chikitsa, Ch.Brahm Prakash Ayurved Charak Sansthan,Khera Dabar, Najafgarh, New Delhi 73.
Ch.Brahm Prakash Ayurved Charak Sansthan,Khera Dabar, Najafgarh, New Delhi 73.
New Delhi
DELHI
110073
India |
| Phone |
7615050724 |
| Fax |
|
| Email |
drneetu90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ch.Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, New Delhi-73 |
|
|
Primary Sponsor
|
| Name |
ChBrahm Prakash Ayurved Charak Sansthan |
| Address |
Ch.Brahm Prakash Ayurved Charak Sansthan,New Delhi |
| 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 NRSingh |
Ch.Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,New Delhi 73 |
Room No. 146 Dept. of Kayachikitsa , Academic Block
New Delhi
DELHI |
9560659728
naimishraj@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Ch.Brahm Prakash Ayurved Charak Sansthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients suffering from Osteoarthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Laksha guggulu |
Patients will be randomly divided in 2 groups of 20 patients in each..
Group A-Laksha guggulu 2 tab TDS orally,
Group B-Laksha guggulu 2 tab TDS orally with 50 ml matra vasti of Panchtiktaguggulu Ghrita.
|
| Intervention |
Panchtiktaguggulu ghrita |
In group B-50 ml matra vasti of panchtikta guggulu ghrita per day with Laksha guggulu 2 tab TDS . |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having the symptoms of osteoarthritis(OA)and having Radiological evidence of OA |
|
| ExclusionCriteria |
| Details |
Age below 40 yrs and above 70 yrs.Patients having Hypertension,Tuberculosis,Diabetes mellitus,Carcinoma,Cardiac disorder,Rheumatoid arthritis. Patients with ligamental injury of knee joint. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Symptoms of osteoarthritis and
Radiological evidence |
16 days with follow ups for 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Swelling of the knee joint,Distance walked by pt.,Movement of knee joint,Pain in joint |
16 days with follow ups for 3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="20"
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 3 |
|
Date of First Enrollment (India)
|
15/05/2018 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
I will select patients ramdomly having symptoms and radiological evidence of Osteoarthritis.Patients will devided into 2 groups (A & B).Drug will be provided to group A -Laksha guggulu 2 tab TDS orally for 16 days and in other group B Laksha guggulu 2 tab TDS orally with Matra vasti of Panchtikta guggulu Ghrita 50 ml per day for 16 days. Screening will be done on first day .Here is plan of study ..PLAN OF STUDY | INTERVENTIONS | DAY 0 | DAY 1 | DAY 2 TO 17 | DAY 18 | DAY 49 | | Screening | ü | | | | | | Physical examination | | ü | | ü | ü | | Assessment of Pain | | ü | | ü | ü | | Movements | | ü | | ü | ü | | Distance walked by Pt. in 15 minutes | | ü | | ü | ü | | Swelling | | ü | | ü | ü | | ESR | | ü | | ü | ü | | X-Ray of knee joint | | ü | | | ü | | Group Allocation | | ü | | | | | Continuation of Treatment | | | ü | | | Then weekly follow ups will be for 3 months after completion of treatment.
|