| CTRI Number |
CTRI/2019/12/022278 [Registered on: 06/12/2019] Trial Registered Prospectively |
| Last Modified On: |
11/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
ayurvedic management of Janusandhigata Vata (Osteoarthritis of Knee joint) with Trayodashanga Guggulu and Yogaraja Guggulu. |
|
Scientific Title of Study
|
“Evaluation of Trayodashanga Guggulu and Yogaraja Guggulu in management of Janusandhigata Vata (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 |
DR DHARA NILESHKUMAR DELIWALA |
| Designation |
PG SCHOLAR |
| Affiliation |
J S AYURVEDA MAHAVIDHYALAYA |
| Address |
Department of Kayachikitsa, J S AYURVEDA MAHAVIDYALAYA,
COLLEGE ROAD
NADIAD,KHEDA
Kheda
GUJARAT
387001
India |
| Phone |
9426712776 |
| Fax |
|
| Email |
drdhara.deliwala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VD TAPAN M VAIDYA |
| Designation |
PROFESSOR |
| Affiliation |
J S AYURVEDA MAHAVIDYALAYA |
| Address |
J S AYURVEDA MAHAVIDYALAYA COLLEGE ROAD NADIAD
Kheda
GUJARAT
387001
India |
| Phone |
9924304388 |
| Fax |
|
| Email |
vdtapan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VD TAPAN M VAIDYA |
| Designation |
PROFESSOR |
| Affiliation |
J S AYURVEDA MAHAVIDYALAYA |
| Address |
J S AYURVEDA MAHAVIDYALAYA COLLEGE ROAD NADIAD
Kheda
GUJARAT
387001
India |
| Phone |
9924304388 |
| Fax |
|
| Email |
vdtapan@gmail.com |
|
|
Source of Monetary or Material Support
|
| SUNDAR AYURVEDA PHARMACY
J S AYURVEDA COLLEGE NADIAD |
|
|
Primary Sponsor
|
| Name |
J S AYURVEDA MAHAVIDYALAYA |
| Address |
J S AYURVEDA MAHAVIDYALAYA COLLEGE ROAD NADIAD 387001 |
| Type of Sponsor |
Private 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 DHARA NILESHKUMAR DELIWALA |
P D PATEL AYURVEDA HOSPITAL |
KAYACHIKITSA AND PANCHAKARMA OPD OF P D PATEL AYURVEDA HOSPITAL
Kheda
GUJARAT |
9426712776
drdhara.deliwala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH |
Approved |
|
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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 |
TRAYODASHANGA GUGGULU |
THERE WILL BE 2 GROUPS EACH WITH 15 PATIENTS ONE GROUP WILL BE GIVEN TRAYODASHANGA GUGGULU ORALLY 3 TABLET THRICE A DAY FOR 6 WEEKS AND OTHER WILL BE GIVEN YOGARAJA GUGGULU WILL ALSO BE GIVEN ORALLY 3 TABLETS THRICE A WEEK FOR 6 WEEKS |
| Comparator Agent |
YOGARAJA GUGGULU
|
YOGARAJA GUGGULU ORALLY 3 TABLETS FOR 6 WEEKS WILL BE GIVEN TO 15 PATIENT IN COMPARE TO TRAYODASHANGA GUGGULU. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient who fulfilling the diagnostic criteria as which will be on the basis of presence of signs and symptoms of Sandhisula, Sandhisotha, Sandhigraha, Akunchana prasaranajanya vedana, Sandhisphutana
2.Patients having age of both genders between 40 to 80 years.
|
|
| ExclusionCriteria |
| Details |
1.Female patients have pregnancy or lactating period.
2.Patient with associated disease which affects the outcomes or completion of the treatment i.e. cardiovascular disorders, osteoporosis, hyperthyroidism or hypothyroidism, cancer, tuberculosis, heart diseases, psoriatic arthritis, kidney and liver disorders.
3.Patients who have taken medication of corticosteroids within last 3 months and anti-inflammatory, analgesics medicine within last 7 days.
4.Patients having age less than 40 and more than 80 years.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EFFECT OF AYURVEDIC MANAGEMENT IN PATIENT OF JANUSANDHIGATA VATA |
patient will be assessed every week for 6 week duration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="27" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2019 |
| Date of Study Completion (India) |
28/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
THIS WILL BE SUBMITTED IN A FORM OF DISSERTATION AND MAY PUBLISHED IN ANY PEER REVIEW JOURNAL WITH PRIOR PERMISSION OF GUJARAT AYURVEDA UNIVERSITY |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
THE PRESENT RESEARCH WORK WAS PERFORMED TO FIND THE EFFECTIVENESS OF AYURVEDIC MANAGMENT IN PATIENT OF JANU SANDHIGATA VATA (OSTEOARTHRITIS OF KNEE JOINT). SANDHIGATAVATA IS ONE OF THE MAJOR CAUSES OF CHRONIC DISABILITY AND AFFECTING THE QUALITY OF LIFE. BOTH AYURVEDA AND MODERN HAVE TYPICAL CLINICAL SYMPTOMS SUCH AS PAIN, STIFFNESS AND INFLAMMATION. TRAYODASANGA GUGGULU AND YOGARAJA GUGGULU BOTH ARE THE ORAL MEDICAMENTS MENTIONED IN MOST AYURVEDIC CLASSIC FOR TREATMENT OF SANDHIGATAVATA. MAIN AIM OF THIS STUDY WAS TO FIND OUT THE DIFFERENCE IN EFFECT OF BOTH THE GROUP WITH THE HELP OF CHANGES OBTAINED IN SIGN AND SYMPTOMS OF SANDHIGATAVATA AS WELL AS WOMAC SCALE, VAS SCALE AND X-RAY. STUDY SHOWED THAT ELDERLY PERSON, OBESE AND PREDOMIENATELY FEMALE WERE MORE PRONE TO OSTEOARTHRITIS. THE ULTIMATE RESULT FOR OA PATIENTS WERE REDUCTION IN SCORE OF WOMAC SCALE, VAS SCALE AND X RAY SCORE. THERE WAS IMPROVEMENT IN THERE DAY TO DAY ACTIVITY. THERE WAS STASTISTICALLY HIGHLY SIGNIFICANT RESULT FOUND IN BOTH GROUP WITH PAIRED AND UNPAIRED T TEST. BOTH MEDICAMENTS WERE VERY EFFECTIVE ON SANDHIGATAVATA BUT IT WAS OBSERVED THAT TRAYODASANGA GUGGULU WAS MORE EFFECTIVE FOR SULA(PAIN). ACCORDING TO X RAY FINDING PATIENTS OF 3 OR 4 GRADES DID NOT GET MUCH RESULTS BUT IN PATIENTS WITH 1 AND 2 GRADES GOT MORE SATISFACTORY RELIEF IN PAIN AND SYMPTOMS. IT SUGGESTS THAT PATIENT WITH LOW GRADES HAVE HIGHER CHANCE OF PROGNOSIS.
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