| CTRI Number |
CTRI/2021/04/032807 [Registered on: 13/04/2021] Trial Registered Prospectively |
| Last Modified On: |
26/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluation of effect of Shallaki, Lepa and Janu Vasti in Patients With Knee Joint Osteoarthritis |
|
Scientific Title of Study
|
Clinical Evaluation of Shallaki and its comparative synergistic effect with Lepa and Janu Vasti in Janusandhigata Vata with special reference to Knee Joint Osteoarthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC / ACA / 2020 /3 -23 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
A M H S Attanayake |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Post Graduate Department of Kayachikitsa
National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur
142 Govind Nagar West Amer road Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9119218397 |
| Fax |
911412635816 |
| Email |
harshamed@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhishek Upadhyay |
| Designation |
Lecturer |
| Affiliation |
National Institute of Ayurveda |
| Address |
Post Graduate Department of Kayachikitsa National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur
Post Graduate Department of Kayachikitsa National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9915613039 |
| Fax |
|
| Email |
dr.abhishek82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhishek Upadhyay |
| Designation |
Lecturer |
| Affiliation |
National Institute of Ayurveda |
| Address |
Post Graduate Department of Kayachikitsa National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur
Post Graduate Department of Kayachikitsa National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9915613039 |
| Fax |
|
| Email |
dr.abhishek82@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurvea |
| Address |
Jorawar Singh Gate, Amer Road,Jaipur, 302002 |
| Type of Sponsor |
Other [Ayurveda University] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Abhishek Upadhyay |
Post graduate Department of Kayachikitsa, National Institute of Ayurveda, Jorawar Singh gate, Amer road, Jaipur, 302002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr A M H S Attanayake |
National Institute of Ayurveda |
Jorawar Singh Gate Amer Road Jaipur 302002
Jaipur
RAJASTHAN |
9119218397
harshamed@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: Janusandhigata Vata, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Shallaki Tablets
|
Shallaki tablets
1 gram TDS orally 15 days,
|
| Comparator Agent |
Shallaki tablets with Ketakyadi Janu Vasti |
Internal application of shallaki 1gram TDS for 15 days and external application of Ketakyadi Taila 250ml Janu Vasti for 15 days |
| Comparator Agent |
Shallaki Tablets with Koladi Lepa |
Internal Application of Shallaki tablet 1 gram TDS for 15 days and external application of Koladi Lepa 30 gram twice a day for 15 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in the age group of 40 to 70 years of either sex.
2. Patients having signs and symptoms of Janusandhigata Vata of Shotha (edema), Vatapurnadriti Sparsha (on palpation revealed as air filled bag) and pain with Prasaran (extension) and Akunchan (flexion) movements.
3. Patients having chronicity of disease Janusandhigata Vata (KOA) for less than 5 years.
4. Patients willing to sign consent form for the clinical trial.
5. Kellgren Lawrence (Radiological scale) of e†≥2
|
|
| ExclusionCriteria |
| Details |
1. Patients below 40 years and above 70 years of age.
2. Patients of Rheumatoid arthritis, Ankylosing and traumatic arthritis.
3. Patients suffering from paralysis, muscular dystrophy, polio affected persons or persons
with bony deformities
4. Patients having systemic conditions such as Tuberculosis, Brucellosis, Osteomyelitis,
Gouty Arthritis, Psoriatic Arthritis and Systemic Lupus Erythematosus
5. Patients having neoplasm of spine and other complicated diseases like CCF, DM,
Uncontrolled HTN, Unstable Angina, Recent MI etc.
6. Patients using anti-inflammatory medicines including Allopathic medicine and
AYUSH medicines.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in pain and stiffness
including signs and symptoms of Janusandhigata Vata of Shotha (edema), Vatapurnadriti Sparsha (on palpation revealed as air filled bag) and pain with Prasaran (extension), Akunchan (flexion) movements and improvement in Knee Injury and Osteoarthritis Outcome Score (KOOS) |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of range of motion |
15 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
30/06/2021 |
| 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
|
No Publication yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, open label, parallel group, single centre, comparative clinical trial evaluating effect of Shallaki and its comparative synergistic effect with Lepa and Janu Vasti in Janusandhigata Vata with special reference to Knee joint Osteoarthritis. Null hypothesis of the study is there is no difference in the treatment outcome of Janusandhigata Vata with special reference to knee joint osteoarthritis when treated with three different interventions of Shallaki, Shallaki with Koladi Lepa or Shallaki with Ketakyadi Janu Vasti. Shallaki will be given 1 gram thrice a day for 15 days in one group and other group will be treated with shallaki 1 gram thrice a day with external application of 30 grams of Koladi Lepa twice a day for 15 days. Third group will be treated with Shallaki 1 gram thrice a day and Janu Vasti with Ketakyadi Taila (250 ml) once a day for 15 days. Site of study will be National Institute of Ayurveda, Jaipur, Rajasthan, India. Primary outcome of the study is reduction of pain and stiffness including sign and symptoms of Janusandhigata Vata of Shota (edema), Vatapurnadriti Sparsha ( on palpation revealed as air filled bag) and pain with Prasarana and Akunchana( extension and flexion) and improvement in Knee injury and osteoarthritis outcome score ( KOOS). Secondary outcome of the study is improvement in the range of motion. |