| CTRI Number |
CTRI/2009/091/000328 [Registered on: 09/02/2010] |
| Last Modified On: |
03/04/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trail to study the efficacy, safety and tolerability of E-OA-07 in Patients with Osteoarthritis of the Knee Joint |
|
Scientific Title of Study
|
An exploratory, randomized, triple-blind, placebo controlled study to investigate the efficacy, safety and tolerability of E-OA-07 in Patients with Osteoarthritis of the Knee Joint |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| VL/080814/EN |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Jayesh Gala |
| Designation |
|
| Affiliation |
|
| Address |
A-1, Om Kamal Bldg, Harsha Park, Chandravarkar Lane,
Borivali (West)
Mumbai
MAHARASHTRA
400092
India |
| Phone |
9869038185/9969309306 |
| Fax |
None |
| Email |
gala_bhavini@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Aliya Shakeel |
| Designation |
|
| Affiliation |
None |
| Address |
203, Morya Landmark 1, Off. New Link Road, Andheri (West)
None
Mumbai
MAHARASHTRA
400053
India |
| Phone |
022-42172306 |
| Fax |
022-66941169 |
| Email |
medical@vediclifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Seema Damakale |
| Designation |
|
| Affiliation |
|
| Address |
118, Morya House, Off. New Link Road, Andheri (West)
None
Mumbai
MAHARASHTRA
400053
India |
| Phone |
022-42172327 |
| Fax |
022-66941169 |
| Email |
clinical@vediclifesciences.com |
|
|
Source of Monetary or Material Support
|
| Exotic Naturals (Sponsor) |
|
Primary Sponsor
Modification(s)
|
| Name |
Exotic Naturals |
| Address |
203, Morya Landmark I,
Off Link road, Andheri(west), Mumbai-400053.
|
| Type of Sponsor |
Other [Herbal extract company - Indian] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Jayesh Gala |
A-1, Om Kamal Bldg, Harsha Park, Chandravarkar Lane, Borivali (West) |
A-1, Om Kamal Bldg, Harsha Park, Chandravarkar Lane, ,Borivali (West)-400092
Mumbai
MAHARASHTRA |
9869038185
None
None |
| Dr. Prakash Thombare |
Aditya Yog and Ayurvedic Prathistan |
Sambhaji Nagar, Chinchwad.,None-411009
Pune
MAHARASHTRA |
9850042832
None
prakashpillu@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Inter System BioMedica Ethics Committee - Dr. Jayesh Gala |
Approved |
| Inter System Biomedica Ethics Committee - Dr. Thombare |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Osteoarthritis of the Knee joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
E-OA-07 |
2 tablets twice daily for 12 weeks |
| Comparator Agent |
Placebo ( Carboxy Methyl Cellulose) |
2 tablets twice daily for 12 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
? Ambulatory adult patients of either sex aged 20-65 years.
? Patients with moderate to severe Osteoarthritis of knee(s), (signal joint) which is clinically detected and/or diagnosed as per Radio logic examination and American Rheumatism Association (ARA) functional classification.
Note - The primary knee joint under study will be nominated as the ?signal joint? while the other affected joint(s), if any, will be termed as ?non-signal joints?.
? ARA functional classes II and III.
? Kellgren Lawrence for Knee Osteoarthritis of Grade II, Grade III.
? Patient?s functional assessment of overall pain score should be ≥ 70 on a 100 mm Pain-Visual analog scale.
? Subjects willing to maintain physical activity levels.
? Subjects with Modified WOMAC score for the signal joint of 60 and above
|
|
| ExclusionCriteria |
| Details |
? Patients of any other arthritis other than Osteoarthritis.
? Patients with severe trauma to the knee joint.
? Arthroscopy of either knee in the past year.
? Administration of intra-articular steroids in the past 3 month or hyaluronic acid in the last 9 months.
? Patients has known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or other contraindication to any compound present in the study medication.
? Patients with DVT or pre-disposed to DVT as evidenced by a score of >0 using Wells criteria for DVT.
? Moderate to severe peripheral neuropathy or other neurological disorders
? Patients requiring immediate Surgery for knee.
? Pregnant / lactating women and women who are planning to get pregnant
? Known hypersensitivity or allergy to one or more of the herbal ingredients
? Recent (< 3 months) participation in a clinical trial
? Major chronic disease of liver, CVS or CNS
? A psychiatric condition, chronic alcohol or drug abuse problem as evidenced by withdrawal symptoms
? Subjects otherwise judged by the investigator to be inappropriate for inclusion in the study
? Patients unwilling to discontinue their current medication for OA.
? Patients with peptic ulcer disease, bleeding diathesis, coagulation disorders, on anti-coagulant therapy
? Patients scheduled for any surgery within 3 months of completing the study.
? Patients with serum cholesterol levels >280 mg% and serum triglyceride levels > 500 mg%
? Patients with serum uric acid levels >8.3 mg%
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of IP in reducing symptoms in osteoarthritis of the signal joint using Modified WOMAC questionnaire as compared to placebo |
Day -7/-15, Day 1, Day 21, Day 42, Day 63, Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) To assess the efficacy of IP in reducing pain of signal and non-signal joint(s) using Pain-VAS as compared to placebo
2) To assess the efficacy of IP in reducing stiffness of signal and non-signal joint(s) using Stiffness ?VAS as compared to placebo
3) To assess the efficacy of IP in improving movement of signal and non-signal joint(s) using Movement ?VAS as compared to placebo
4) To assess the efficacy of IP by improvement in performance of a) timed up-and-go test, b) unilateral anterior reach test and c) medial step-down test as compared to placebo
5) To assess the efficacy of IP in improving signal joint mobility as measured by goniometry as compared to placebo
6) To assess the safety and tolerability of the IP
7) To assess the efficacy of the IP in reducing the use of rescue medication as compared to placebo
8) To assess the carryover efficacy of the IP as measured by number of days for which subject stays medication-free after stopping the IP as compared to placebo
|
1) Signal Joints - Dy -7/-15, Day 1, Day 21, Day 42, Day 63, Day 84. Non - Signal Joints - Day 1 & Day 84
2) Signal Joints - Dy -7/-15, Day 1, Day 21, Day 42, Day 63, Day 84. Non - Signal Joints - Day 1 & Day 84
3) Signal Joints - Dy -7/-15, Day 1, Day 21, Day 42, Day 63, Day 84. Non - Signal Joints - Day 1 & Day 84
4) Day 1, Day 42 & Day 84
5) Goniometry
6) Day 42 & Day 84
7) Day 100 & Day 130
8) Day 130 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
28/05/2009 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ambulatory adult patients of either gender aged 20 to 65 years of age (n = 24 + 12=36) will be included, out of which 24 will be completed cases. Recruitment of patients will be done through the investigator?s own direct contact patients or patient referral to the selected investigators.
For each patient, the study will terminate after a maximal period of 130 days from baseline and this study will include 8 visits (including the screening visit)
If the subject is taking allopathic medication for the indication, then a washout period of 7 days would be provided & for the subjects consuming herbal/ayurvedic medication, the washout period of 15 days would be given.
In the case of new patients, on the day of the screening visit (day -7 to -15), the patient?s medical history will be taken and a physical examination will be performed to help arrive at a diagnosis of osteoarthritis of the knee. Then the patient will be informed about the trial and a thorough explanation will be given to each patient about the aims and course of the study, as well as a full explanation of the dosage, mode of administration, safety and efficacy of E-OA-07 (A poly herbal ayurvedic Tablets containing shallaki, Ashwagandha & shyonak). After reading, understanding and signing an informed consent, the patient will be assessed for the inclusion/exclusion criteria. Thereafter, rescue medication - Acetaminophen tablets (1 tablet upto a maximum of 4 tablets daily) will be given to the patients to be taken during the washout period of 7 days till the beginning (Day 1) of the trial in case of unbearable pain.
The knee joint will be examined radiographically. Blood (fasting) and urine samples will be taken for determination of safety parameters as well as to exclude patients whose health status would not be suitable for trial participation. An ECG will also be performed. Wells scoring for DVT, Pain- VAS for the signal joint, ARA grading and Kellgren Lawrence grading of the affected knee will be done. WOMAC score will also be done to ensure that the patient fits into the inclusion criteria. Before the baseline visit (day 1), the X-ray, ECG, blood and urine reports will be assessed. If the patient satisfies the criteria for inclusion, he/she will be randomized into the study.
On day 1, all the necessary clinical examinations, WOMAC scoring, Pain-VAS, Stiffness- VAS and Movement ? VAS for signal and non-signal joints, goniometry for signal joints, timed up-and-go test, unilateral anterior reach test and medial step-down test will be performed. AE/ SAE Monitoring will be done. The trial medication and rescue medication will be dispensed according to the randomization chart. Rescue medication accountability would be done to find out rescue medication consumption during the washout period. Subjects will be asked to fill a physical activity questionnaire (PAQ) to ensure that their physical activities are maintained at a relatively constant level for the duration of the trial.
The subsequent 4 visits will be scheduled at 3 week intervals (visit 3 = day 21, visit 4 = day 42, visit 5 = 63 and visit 6 = day 84) at which each patient will receive another supply of the trial medication and rescue medication. Leftover trial medication will be returned to the physician at visit 3, visit 4, visit 5 and visit 6. IP and rescue medication accountabilities will be noted. At all these visits, clinical examinations will be repeated. Also, WOMAC scores, Pain-VAS, Stiffness-VAS and Movement?VAS for signal joints will be obtained. AE/ SAE monitoring would be performed. PAQs will be filled for each of these visits.
Visit 7 ,day 100 will be done for follow up purposes to determine whether the effect of the trial medication is carried over for at least 15 days after stopping the IP. During this period, rescue medication will be provided to the trial subjects.
On day 42, in addition to these tests, timed up-and-go test, unilateral anterior reach test and medial step-down test and goniometry will be performed. Also, patient opinion and investigator?s global assessment will be taken at this visit. An interim analysis will be done after day 42 visit upon the data of 16 patients who will be recruited into the study. The decision to continue the trial will be taken by the sponsor depending upon the results of the data analysis.
At the 6th visit on day 84 the patients will be assessed for overall improvement by general, systemic and local examination. ECG will be performed and blood (fasting) and urine will be taken for determination of the safety parameters. WOMAC score, Pain-VAS, Stiffness-VAS and Movement-VAS for signal and non-signal joints, goniometry for signal joints, timed up-and-go test, unilateral anterior reach test and medial step-down test will be performed. Global assessment has to be done by the investigator and patient opinion has to be taken at this visit. The test medications will be taken back from all subjects and rescue medication will be dispensed to them. IP and rescue medication accountability will also be done at this visit.
Subjects will be asked to come for a 7th visit i.e on day 100, to check the effect of the trial medication. Along with clinical examinations, Pain-VAS, Stiffness - VAS and Movement-VAS for signal joint will be done. PAQs will have to be filled. Rescue medication accountability will be done at this visit. Rescue medicines will not be provided at day 100 visit.
On day 130 (visit 8), follow up with the subjects will be done with a view to finding out the carry over effect of the IP. This will be assessed using Pain, movement, stiffness VAS for signal joint and any medication used between day 100 and day 130 for OA symptoms.
On visits 7 & 8 also, AE ? SAE monitoring will be done.
|