| CTRI Number |
CTRI/2015/09/006177 [Registered on: 11/09/2015] Trial Registered Prospectively |
| Last Modified On: |
06/11/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of AHPL/AYTAB/0313 in patients suffering from arthritis of knee(s) |
|
Scientific Title of Study
|
A clinical study to evaluate efficacy and safety of AHPL/AYTAB/0313 in subjects suffering from osteoarthritis of knee(s) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHPL/AYTAB/0313/2015/CT-1; Version No: 2, date: 20.07.2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shailesh Deshapande |
| Designation |
Assistant Professor, Department of Kayachikitsa |
| Affiliation |
Pune District Education Associations, College of Ayurved & Research Centre and Hospital |
| Address |
Pune District Education Associations,
College of Ayurved & Research Centre and Hospital, Sector No. 25, Pradhikaran, Nigdi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9763104451 |
| Fax |
|
| Email |
dr.shaileshd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Nipanikar |
| Designation |
Head - R & D Centre |
| Affiliation |
Ari Healthcare Pvt. Ltd. |
| Address |
Ari Healthcare Pvt. Ltd, R & D Centre, Unit No 401, International Biotech Park, BTS 2 Building, Chrysalis Enclave, 4th floor, Plot No 2A, MIDC Phase-II Hinjewadi,
Pune
Pune
MAHARASHTRA
411057
India |
| Phone |
8550990792 |
| Fax |
|
| Email |
sanjay.n@arihealthcare.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Nipanikar |
| Designation |
Head - R & D Centre |
| Affiliation |
Ari Healthcare Pvt. Ltd. |
| Address |
Ari Healthcare Pvt. Ltd, R & D Centre, Unit No 401, International Biotech Park, BTS 2 Building, Chrysalis Enclave, 4th floor, Plot No 2A, MIDC Phase-II Hinjewadi,
Pune
MAHARASHTRA
411057
India |
| Phone |
8550990792 |
| Fax |
|
| Email |
sanjay.n@arihealthcare.in |
|
|
Source of Monetary or Material Support
|
| Ari Healthcare Pvt. Ltd. R & D Centre, Unit No 401 International Biotech Park BTS 2 Building, Chrysalis Enclave 4th floor Plot No 2A MIDC Phase-II Hinjewadi Pune |
|
|
Primary Sponsor
|
| Name |
Ari Healthcare Pvt Ltd |
| Address |
R & D Centre, Unit No 401 International Biotech Park BTS 2 Building, Chrysalis Enclave 4th floor Plot No 2A MIDC Phase-II Hinjewadi Pune |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Shailesh Deshapande |
Pune District Education Associations, College of Ayurved & Research Centre and Hospital |
2nd Floor, Sector No. 25, Pradhikaran, Nigdi, Pune
Pune
MAHARASHTRA |
9763104451
dr.shaileshd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Pune District Education Associations, College of Ayurved & Research Centre and Hospital, Sector No. 25, Pradhikaran, Nigdi, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Osteoarthritis of Knee(s), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AHPL/AYTAB/0313 Tablet |
Each film coated tablet contains extracts of Shallaki (Boswellia serrata), Guggulu (Commiphora mukul), Rasna (Pluchea lanceolata), Ashvagandha (Withania somnifera), Nirgundi (Vitex negundo), Guduchi (Tinospora cordifolia), Eranda (Ricinus communis), Shunthi (Zingiber officinale). Dose & Treatment Duration: Two tablets 2 times a day orally after meals with water for 180 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Subject willing to participate, who have read, understood and signed informed consent form
2.Subject with history of knee pain due to osteoarthritis requiring use of NSAIDs acetaminophen, or another analgesic agent on a regular basis (greater than or equal to 3 days per week) for at least 6 months before the screening visit.
3.OA confirmed by radiographs and diagnosed according to ACR diagnostic criteria (clinical and radiological) for the OA of the knee.
4.Subjects are willing to make all required study visits
5.Subjects are willing to follow study instructions given by the investigator
|
|
| ExclusionCriteria |
| Details |
1.Subjects refused to give their informed consent
2.Subjects with rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease
3.Subjects with history of surgery, including arthroscopy, or major trauma to the study joint in the previous six months before the screening visit
4.Subjects requiring knee arthroplasty within 6 months of screening or anticipating any need for a surgical procedure on the index joint during the study
5.Subjects with signs of clinically important active inflammation of the study knee joint including redness, warmth and or a large, bulging effusion with the loss of normal contour at the screening and or baseline visits
6.Subjects using systemic corticosteroids within 2 months of screening, or intraarticular visco-supplementation within the past 3 months
7.Subjects with any other investigational drug within 1 month prior to randomization;
8.Subjects having diabetes mellitus, tuberculosis, HIV, ischemic heart disease
9.Subjects with known major medical or surgical disease
10.Pregnant and lactating women
11.Subjects with known hypersensitivity to ingredients used in study drug.
12.Subjects with significant abnormal laboratory parameters
13.ECG demonstrating any signs of uncontrolled arrhythmia and or acute ischemia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of efficacy of AHPL/AYTAB/0313 tablet by assessing knee joint pain on VAS and by assessment of WOMAC Index |
Screening Visit (day -7), Baseline Visit (day 0), Visit 1 (day 30), Visit 2 (day 60), Visit 3 (day 90), Visit 4 (day 120), Visit 5 (day 150) and Visit 6 (day 180). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Quality of life on SF -36 questionnaire
2.Time to walk 50 feet on even surface
3.Knee joint swelling on graded scale
4.Global assessment for overall improvement by the subject and investigator at the end of 180 days of study treatment
5.Use of analgesic drug as rescue medicine
6.Tolerability of the study drug evaluated by number of Adverse Drug Reactions
7.Safety laboratory investigations
|
Screening Visit (day -7), Baseline Visit (day 0), Visit 1 (day 30), Visit 2 (day 60), Visit 3 (day 90), Visit 4 (day 120), Visit 5 (day 150) and Visit 6 (day 180). |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/09/2015 |
| 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)
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
Modification(s)
|
This study is an open label, interventional, single center, prospective clinical study to evaluate efficacy and safety of AHPL/AYTAB/0313 in subjects suffering from osteoarthritis of knee(s). The study will be conducted in 56 patients suffering from osteoarthritis of knee(s). The study will be conducted at Pune District Education Association’s, College of Ayurved & Research Centre and Hospital, Sector No. 25, Pradhikaran, Nigdi, Pune- 411 044, India. The primary outcome will be to evaluate the efficacy of AHPL/AYTAB/0313 by assessing knee joint pain on VAS and by assessing WOMAC Index score [on day -7, day 0, day 30, day 60, day 90, day 120, day 150 and day 180]. The secondary objectives will be to evaluate the efficacy of AHPL/AYTAB/0313 by assessing subject’s quality of life on SF-36 questionnaire, time required by subjects to walk 50 feet on even surface, knee joint swelling on graded scale, use of analgesic drug as rescue medicine [on day -7, day 0, day 30, day 60, day 90, day 120, day 150 and day 180]. The secondary objectives will be to evaluate the safety of AHPL/AYTAB/0313 by assessing laboratory investigations [on day -7 and day 180] and tolerability of the study drug with numbers of ADR [on day 180]. Also, clinical global evaluation for overall improvement by physician and by the patient will be assessed as secondary outcome on day 180. |