| CTRI Number |
CTRI/2018/05/014093 [Registered on: 24/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
31/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Asthisharinkhala Ghana Guggulu in the management of Osteoarthritis |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF ASTHISHARINKHALA GHANA IN THE MANAGEMENT OF OSTEOARTHARIRIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
kshiteeja choudhary |
| Designation |
MD |
| Affiliation |
Rishikul campus haridwar |
| Address |
Rishikul Campus Haridwar
Uttarakhand Ayurveda University Deharadun
Department of Panchakarma
Rishikul Campus, Haridwar
Pin Code-249401
Hardwar
UTTARANCHAL
249401
India |
| Phone |
09001214122 |
| Fax |
|
| Email |
choudharykshiteeja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Alok Kumar Srivastava |
| Designation |
Associate Professor |
| Affiliation |
Rishikul campus haridwar |
| Address |
Department of Panchakarma
Rishikul Campus, Haridwar
Department of Panchakarma
Rishikul Campus, Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9045087121 |
| Fax |
|
| Email |
virgo.alok@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Alok Kumar Srivastava |
| Designation |
Associate Professor |
| Affiliation |
Rishikul Campus, Haridwar |
| Address |
Department of Panchakarma
Rishikul campus, Haridwar
Uttarakhand Ayurveda Uviversity Dehradun
Department of Panchakarma
Rishikul Campus Haridwar
Uttarakhand Ayurveda University, Deharadun
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9045087121 |
| Fax |
|
| Email |
virgo.alok@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus, Haridwar Uttarakhanda Ayurveda University Deharadun |
|
|
Primary Sponsor
|
| Name |
OPD and IPD department of panchakarma |
| Address |
departmrnt of panchakarma, rishikul campus, haridwar |
| 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 |
| Kshiteeja Choudhary |
Rishikul Campus, Haridwar |
opd no. 20
Department of Panchakarma
Hardwar
UTTARANCHAL |
9001214122
choudharykshiteeja@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
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, patient with osteoarthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
asthisharinkhala ghana guggulu |
Asthishrankhala Ghana Guggulu 2 tab B.D (1 gram), with the Anupana of Ushna Jala for 30 days |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a. Having sign and symptoms of Sandhivata (Osteoarthritis) as given below:
1. Sandhi Shula (pain in the joint)
2. Sandhi Shotha (Swelling in the joints)
3. Sandhigraha (Morning Stiffness)
4. Akunchana Prasaranayoh Vedana (Pain during Flexion and extension)
5. Sparsha Asahyata (Tenderness)
6. Sandhisphutana (Cracking of the joints)
7. Crepitus in the joint.
b. Diagnostic Findings:
1. Radiologic Osteophytes (If present)
c. Chronicity less than or equal to 5 years
|
|
| ExclusionCriteria |
| Details |
1. Patients below 30 and above 70 years of age.
2. Cases which require surgical intervention will be excluded.
3. Patient, suffering from any chronic debilitating disease like T.B., D.M., Rheumatoid Arthritis, Gout, Varicose veins, Asthma & other chronic problems etc. and having other serious pathology.
4. Pregnant lady and lactating mother
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of therapy all sign and symptoms were
given scoring depending upon there severity.
1. Complete relief : 100%
2. Marked improvement : 76% to 99
3. Moderate improvement : 51% to 75 %
4. Mild improvement : 26 % to 50 %
5. No improvement : 0% to 25 % |
2 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Exacerbation in signs and synptoms |
30 DAYS |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
26/03/2018 |
| Date of Study Completion (India) |
06/05/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Osteoarthritis (OA), which is also known as osteoarthrosis or degenerative joint disease (DJD), is a progressive disorderof the joints caused by gradual loss of cartilage and resulting in the development of bony spurs and cysts at the margins of the joints.The condition similar to Osteoarthritis has been described as ‘Sandhigatavata’ in Ayurveda, in which the vitiated Vata afflicts the joints and causes destruction of the cartilages and reduction in the synovial Fluid inside the joint capsule, leading to swelling which results into painful movement. Ayurvedic treatment of Osteoarthritis prevents further deterioration in the joints and rejuvenates damaged cartilages. Vata-alleviating treatments through specific herbs are suggested for lubrication and strengthening of joints.
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