| CTRI Number |
CTRI/2018/06/014459 [Registered on: 07/06/2018] Trial Registered Prospectively |
| Last Modified On: |
06/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of some ayurvedic medicine in the management janu sandhigata vata (Osteoarthritis of Knee Joint |
|
Scientific Title of Study
|
Comparative Study of Adityapaka Guggulu with Janu Basti and Sandhivatari Gutika with Janu Basti in the Management of Janusandhigata Vata with special reference to 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 |
Prof Ram Kishor Joshi |
| Designation |
Professor and Head of the Department |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Kayachikitsa National Institute of Ayurveda
Jorawar Singh Gate , Madhav Villas Palace , Amer Road Jaipur Rajasthan 302002 India
Madhav Villas Palace, Amer Road Jaipur RAJASTHAN 302002 India
Jaipur RAJASTHAN 302002 India |
| Phone |
9414322297 |
| Fax |
|
| Email |
joshirk1964@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Ram Kishor Joshi |
| Designation |
Professor and Head of the Department |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Kayachikitsa National Institute of Ayurveda
Jorawar Singh Gate , Madhav Villas Palace , Amer Road Jaipur Rajasthan 302002 India
Madhav Villas Palace, Amer Road Jaipur RAJASTHAN 302002 India
Jaipur RAJASTHAN 302002 India |
| Phone |
9414322297 |
| Fax |
|
| Email |
joshirk1964@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Bijay Shrestha |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Kayachikitsa National Institute of Ayurveda,
Madhav Villas Palace, Amer Road Jaipur RAJASTHAN 302002 India
Madhav Villas Palace, Amer Road Jaipur RAJASTHAN 302002 India Jaipur RAJASTHAN 302002 India |
| Phone |
9079854761 |
| Fax |
|
| Email |
doc.bijay@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Madhav Villas Palace, Amer Road Jaipur RAJASTHAN 302002 India
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prof Ram Kishor Joshi |
National Institute of Ayurveda Hospital |
OPD room no 1, 18, 25
PG Department of Kayachikitsa,
Madhav Villas Palace, Amer Road Jaipur RAJASTHAN 302002 India
Jaipur RAJASTHAN |
9414322297
joshirk1964@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Janusandhigata vata ( osteoarthritis of knee joint), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adityapaka Guggulu with janu basti |
Adityapaka Guggulu 2 tablets (each tablet of 500mg)twice daily after meal with luke warm water for 30 days with Janu basti daily for 45 minutes for 14 days with Nirgundi tailam |
| Comparator Agent |
Sandhivatari gutika with janu basti |
Sandhivatari gutika 2 tablets (each tablet of 500mg) twice daily with warm water after meal for 30 days with Janu basti daily for 45 minutes for 14 days with Nirgundi tailam. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
i. Patient willing to sign the consent form.
ii. Patients between the ages of 30-60 years of either sex.
iii. Patients with signs and symptoms of Janusandhigata Vata.
iv. Patients with OA changes in X-ray.
v. Patients with chronicity of less than 5 years.
|
|
| ExclusionCriteria |
| Details |
i. Patients suffering from paralysis.
ii. Patients of rheumatoid arthritis, gout, ankylosing spondylitis and traumatic arthritis.
iii. Patients having septic arthritis, tuberculosis, brucellosis, pyogenic osteomyelitis, etc.
iv. Patients having malignancy and other complicated diseases like Congestive Cardiac Failure (CCF), Diabetes Mellitus, Malignant Hypertension, etc.
v. Patients having severe osteoarthritic changes.
vi. Patients with bony deformity.
vii. Pregnant and lactating mother.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients of either sex of 30 to 60 years old diagnosed as Janu sandhigata vata (Osteoarthritis of knee joint) will be selected for relief in sign and symptoms. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the efficacy of Adityapaka Guggulu with Janu Basti and Sandhivatari Gutika with Janu Basti in the Management of Janusandhigata Vata with special reference to Osteoarthritis of Knee Joint. |
30days |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/08/2018 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Osteoarthritis is
the most prevalent form of arthritis in India, affecting over 15 million adults
every year. It is the disease of old age and by 2020, the number of 65 years
and above population in India is likely to be about 177 million. India may
become the osteoarthritis capital of the world with over 60 million cases of
the diseases by 2025. Despite the advancement in using new drugs and techniques, the management of
Osteoarthritis with analgesics, corticosteroids and surgical procedure (total
knee replacement) in Allopathic medicine is either temporary or very costly and
also having many side effects. Ayurveda
is the best alternative option. In Ayurveda,
Sandhigata Vata is managed by Snehana, Swedana, Upanaha and Vata Shamak drugs. Among the wide
varieties of drugs mentioned in Ayurveda
text books, Adityapaka Guggulu and Sandhivatari Gutika have been chosen for
the study so as to re-establish their efficacy which may contribute to the
successful treatment of Sandhigata Vata
(OA). Adityapaka guggulu which has been mentioned invVatavyadhi
prakaran of Chakradatta contains triphala, pipplai, tvak, ela
and guggulu processed in dashmool kvatha. Similarly, Sandhivatari
Gutika which has been mentioned in Uttarkhanda, Amavata Chikitsha of
Rasachandansu contains rakta bola, hingula and guggulu. The
contents of these drugs are easily available and cheaper. They are easy to use
as there is no special measure or precaution that needs to be taken during
their administration. The efficacy of these two drugs will be assessed and compared.
In both cases Janu Basti with Nirgundi
tailam will also be done.
|