| CTRI Number |
CTRI/2015/02/005489 [Registered on: 02/02/2015] Trial Registered Retrospectively |
| Last Modified On: |
21/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical study to assess effectiveness and safety of ayurvedic products ostikot tablet, rhukot plus cream and rhukot liniment in patients with osteo arthritis of knee |
|
Scientific Title of Study
|
A Single Center Open label, Randomized Controlled Pilot Clinical Study to Assess and Compare the Efficacy and Tolerability of a combination of Ostikot oral tablets (three 1 g tablets twice daily) and Rhukot Plus cream external application v/s Ostikot oral tablets (three 1 g tablets twice daily) and Rhukot Liniment external application v/s Ostikot tablet (three 1 g tablets twice daily) alone in Subjects with Osteo Arthritis of Knee over a period of 12 weeks |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CLIN-AVS-OKT-02 version 00 dated 12/04/2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrPraveenM |
| Designation |
Senior Physician |
| Affiliation |
Vaidyaratnam P. S. Variers Arya Vaidya Sala, Kottakkal |
| Address |
Vaidyaratnam P. S. Variers
Arya Vaidya Sala, Kottakkal
Charitable Hospital
Kottakkal (P.O.),
Malappuram (Dist.),
Kerala – 676 503,
INDIA.
Malappuram
KERALA
676 503
India |
| Phone |
04842742212 |
| Fax |
|
| Email |
varier.praveen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSreejith Sreekumar |
| Designation |
Chief Executive Officer |
| Affiliation |
Clinfound Clinical |
| Address |
Clinfound Clinical Research Services Pvt. Ltd
832 C1, AR3 Annexe,
Seaport-Airport Road, Near Vallathol jn,
Thrikkakara (P.O), Cochin-682 021
Kerala, India.
Ernakulam
KERALA
682021
India |
| Phone |
0484-606-2400 |
| Fax |
|
| Email |
drsreejith@clinfound.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSreejith Sreekumar |
| Designation |
Chief Executive Officer |
| Affiliation |
Clinfound Clinical |
| Address |
Clinfound Clinical Research Services Pvt. Ltd
832 C1, AR3 Annexe,
Seaport-Airport Road, Near Vallathol jn,
Thrikkakara (P.O), Cochin-682 021
Kerala, India.
KERALA
682021
India |
| Phone |
0484-606-2400 |
| Fax |
|
| Email |
drsreejith@clinfound.com |
|
|
Source of Monetary or Material Support
|
| Vaidyaratnam P. S. Variers
Arya Vaidya Sala, Kottakkal |
|
|
Primary Sponsor
|
| Name |
Clinfound Clinical Research Services PvtLtd |
| Address |
Clinfound Clinical Research Services Pvt. Ltd
832 C1, AR3 Annexe,
Seaport-Airport Road, Near Vallathol jn,
Thrikkakara (P.O), Cochin-682 021
Kerala, India. |
| Type of Sponsor |
Contract research organization |
|
|
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 PraveenM |
Vaidyaratnam P. S. Variers Arya Vaidya Sala, Kottakkal Charitable Hospital |
Room No.S1
Sandhivatam OP
Kottakkal (P.O.),
Malappuram (Dist.),
Kerala – 676 503,
INDIA.
Malappuram
KERALA |
04832806603
varier.praveen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aryavaidyasala Institutional Ethics Committe,Kottakkal,Kerala |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ostikot Oral Tablets 1g tablets will be given in a dose of 3 each will be given twice daily over a period of 12 weeks |
The tablets are prepared under GMP at vaidyaratnam PS Variers Aryavaidyasala, Kottakkal |
| Comparator Agent |
Rhukot Plus cream external application combination with Ostikot oral tablets (three 1 g tablets twice daily) over a period of 12 weeks |
Both ostikot tablets and rhukot plus cream are prepared under GMP at vaidyaratnam PS Variers Aryavaidyasala, Kottakkal |
| Comparator Agent |
Rhukot Liniment external application in combination with Ostikot oral tablets (three 1 g tablets twice daily) over a period of 12 weeks |
Both ostikot tablets and Rhukot Liniment are prepared under GMP at vaidyaratnam PS Variers Aryavaidyasala, |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed with idiopathic KOA according to the clinical guidelines of the American College of Rheumatology. The guidelines include patients currently experiencing pain in one or both knees with at least 3 of the following 6 conditions: 1) aged 50 to 70 years, 2) morning stiffness within 30 minutes of waking, 3) crepitus, 4) bony tenderness, 5) bony enlargement, and 6) no palpable warmth.
2.VAS score during the most painful knee movement between 40-70 mm
3.Lequesne’s functional index score between 6-10 points
4.Patients ready to give written informed consent and willing to comply the study protocol
|
|
| ExclusionCriteria |
| Details |
1.Inflammatory diseases, including rheumatoid arthritis
2.Cancer
3.Traumatic injury that might be related to the current knee pain
4.Autoimmune disease
5.Uncontrolled hypertension
6.Diabetes mellitus requiring insulin injection
7.Life-threatening cardiovascular or neurological events within the past year
8.Pregnant and lactating women
9.Chronic respiratory disease
10.Hemorrhagic disorder
11.Alcohol or drug addiction
12.Active infectious disease, including tuberculosis
13.Significant knee joint deformity
14.Knee replacement surgery for the affected knee
15.Knee arthroscopy within the past 2 years
16.Steroid injection in the knee joints within the past 3 months
17.Viscosupplement injections in the knee joints within the past 6 months
18.Joint fluid injection within the past 6 months
19.Acupuncture, Ayurvedic Therapy, or herbal medicine within the past 4 weeks.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome with respect to the effectiveness on KOA will be the mean change in the global scale value of the Western Ontario and McMaster Osteoarthritis Index (WOMAC) from baseline to 12 weeks. |
Baseline week 2 week 4 week 6 week 8 week 10 week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in VAS From Baseline to End of Treatment
2. Change in LFI from Baseline to End of Treatment
3. Changes in ESR From Baseline to End of Treatment |
Baseline week 2 week 4 week 6 week 8 week 10 week 12 |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/10/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
This
is a randomized pilot, open labelled, prospective, single-center study to
evaluate and compare the efficacy and safety of a combination of Ostikot oral
tablets (three 1 g tablets twice daily) and Rhukot Plus cream v/s Ostikot oral
tablets (three 1 g tablets twice daily) and Rhukot Liniment v/s Ostikot tablet alone
(three 1 g tablets twice daily) in Subjects with Osteo Arthritis of Knee. All medicines used as Ayurvedic formulations prepared by Vaidyaratnam PS Varier’s Aryavaidyasala, Kottakkal. Ostikot tablets contain Alpinia galanga,Cassia fistula,Zingiber officinale,Tribulus
terrestris,Ricinus communis,Boerhaavia diffusa and Commiphora mukul. Rhukot plus cream contains Azadirachta indica,Cedrus deodara,Mentha
specieses,Cinnamomum camphora and Gaultheria fragrantissima, Rhukot liniment contains Cedrus deodara,Azadirachta
indica,Camphora officinaram,Gaultheria fragrantissima and Mentha specieses. The clinical study is for a duration of 12 weeks for each subject and will recruit a total of 75 subject (25 in each group
|