CTRI/2012/05/002672 [Registered on: 21/05/2012] Trial Registered Retrospectively
Last Modified On:
28/02/2014
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical study to evaluate efficacy and safety of Seven Different Topical Formulations in Subjects Suffering from Osteoarthritis of Knee(s)
Scientific Title of Study
An Open Labeled, Randomized, Prospective, Multi-center, Phase II, Clinical Study to Evaluate Comparative Efficacy and Safety of Seven Different Topical Formulations in Subjects Suffering from Osteoarthritis of Knee(s)
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
EM/OA/01/2011
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Raman Ghungralekar
Designation
Professor and Head
Affiliation
R. A. Podar Medical College (Ayu) & M. A. Podar Hospital, Worli, Mumbai-18
Address
Department of Kayachikitsa,
R. A. Podar Medical (Ay) College, and M. A. Podar Hospital,Dr. Annie Besant Road, Worli, Mumbai 18
Mumbai MAHARASHTRA 400018 India
Phone
9221100630
Fax
Email
drramanatpodar@gmail.com
Details of Contact Person Scientific Query
Name
Dr Sanjay Tamoli
Designation
Director
Affiliation
TARGET INSTITUTE OF MEDICAL EDUCATION & RESEARCH, Mumbai
Address
TARGET INSTITUTE OF MEDICAL EDUCATION & RESEARCH
(TIMER)205, B Wing, Blue Diamond Society, Nayagoan, Dahisar (West), Mumbai
Mumbai MAHARASHTRA 400068 India
Phone
09322522252
Fax
Email
sanjaytamoli@hotmail.com
Details of Contact Person Public Query
Name
Dr Sanjay Tamoli
Designation
Director
Affiliation
Address
TARGET INSTITUTE OF MEDICAL EDUCATION & RESEARCH
(TIMER)205, B Wing, Blue Diamond Society, Nayagoan, Dahisar (West), Mumbai
MAHARASHTRA 400068 India
Phone
09322522252
Fax
Email
sanjaytamoli@hotmail.com
Source of Monetary or Material Support
Emami Limited.
5th Floor, Golden Chambers,
New Link Road, Andheri (W),
Mumbai -400053, India.
Composition
Pudina ka phool (Menthol) (Mentha arvensis), Gaultheria ka Tel (Wintergreen oil) (Gaultheria procumbens), Nilgiri ka Tel (Eucalyptus Oil) (Eucalyptus globules), Tarpin ka tel (Tarpentine oil) (Pinus longifolia) Ointment Base QS to make 100%
Dosage and Treatment Duration: Sufficient quantity of drug on index knee joint twice daily for 28 days.
Comparator Agent
FR 32
Composition
Pudina ka phool (Menthol) (Mentha arvensis), Gaultheria ka Tel (Wintergreen oil) (Gaultheria procumbens), Nilgiri ka Tel (Eucalyptus Oil) (Eucalyptus globules), Tarpin ka tel (Tarpentine oil) (Pinus longifolia), Lavang ka tel (Clove oil) (Syzygium aromaticum) Ointment Base QS to make 100%
Dosage and Treatment Duration: Sufficient quantity of drug on index knee joint twice daily for 28 days.
Comparator Agent
FR 43
Composition
Diclofenac Diethylamine, Linseed Oil, Menthol, Methyl salycilate, Base to make 100%
Dosage and Treatment Duration: Sufficient quantity of drug on index knee joint twice daily for 28 days.
Intervention
FR 54
Composition:
Pudina ka phool (Menthol) (Mentha arvensis), Karpoor (Cinnamomum comphora), Gaultheria ka Tel (Wintergreen Oil) (Gaultheria procumbens), Ajwain ka Phool (Carum copticum), Nilgiri ka Tel (Eucalyptus Oil) (Eucalyptus globules), Tarpin ka Tel (Turpentine Oil), Lavang ka Tel (Clove Oil), (Syzygium aromaticum), Tejpatta ka Tel (Cinnamomum tamala), Dalchini ka Tel (Cinnamomum zeylanicum), Capsicum Extract (Capsicum annuum) Ointment base
Dosage and Treatment Duration:
Sufficient quantity of drug on index knee joint twice daily for 28 days.
Comparator Agent
FR 68
Composition
Pudina ka phool (Menthol) (Mentha arvensis), Karpoor (Camphor) (Cinnamomum camphora), Ajowan ka phool (Thymol) (Thymus vulgaris), Gaultheria ka Tel (Wintergreen Oil) (Gaultheria procumbens), Nilgiri ka Tel (Eucalyptus Oil) (Eucalyptus globules) Tarpin ka Tel (Tarpentine Oil) (Pinus longifolia), Lavang ka Tel (Clove Oil) (Syzygium aromaticum), Dalchinni ka Tel (Cinammon Oil) (Cinnamomum zeylanicum), Capsicum oleoresin (IFF),Tejpata ka Tel (Cassia Oil) (Cinnamomum tamala) Rosemary Oil (Rosmarinus officinalis) base qs
Dosage and Treatment Duration: Sufficient quantity of drug on index knee joint twice daily for 28 days.
Comparator Agent
FR 70
Composition
Pudina ka phool (Menthol) (Mentha arvensis), Karpoor (Camphor) (Cinnamomum camphora), Ajowan ka phool (Thymol) (Thymus vulgaris), Gaultheria ka Tel (Wintergreen oil) (Gaultheria procumbens), Nilgiri ka Tel (Eucalyptus Oil) Eucalyptus globules, Tarpin ka tel (Tarpentine oil) Pinus longifolia, Lavang ka tel (Clove oil) (Syzygium aromaticum), Dalchinni ka tel (Cinammon oil) (Cinnamomum Zeylanicum), Capsicum oleoresin (IFF) Capsicum extract, Tejpata ka tel (Cassia oil) (Cinnamomum tamala), Rosemary oil (Rosmarinus officinalis), Shalki guggul oil (Balsamodendron mukul), Ointment Base
Dosage and Treatment Duration: Sufficient quantity of drug on index knee joint twice daily for 28 days.
Comparator Agent
FR 72
Composition
Pudina ka phool (Menthol) (Mentha arvensis), Karpoor (Camphor) (Cinnamomum camphora), Ajowan ka phool (Thymol) (Thymus vulgaris,) Gaultheria ka Tel (Wintergreen oil) (Gaultheria procumbens), Nilgiri ka Tel (Eucalyptus Oil) (Eucalyptus globules), Lavang ka tel (Clove oil) (Syzygium aromaticum) Dalchinni ka tel (Cinammon oil) (Cinnamomum Zeylanicum) Tarpin ka tel (Tarpentine oil) (Pinus longifolia), Tejpata ka tel (Cassia oil) (Cinnamomum tamala) Capsicum oleoresin (IFF) Cream Base
Dosage and Treatment Duration: Sufficient quantity of drug on index knee joint twice daily for 28 days.
Inclusion Criteria
Age From
40.00 Year(s)
Age To
70.00 Year(s)
Gender
Both
Details
•Symptoms of osteoarthritis in one or both knee joints for a minimum of six months and maximum for five years
• History of knee pain due to osteoarthritis requiring the use of NSAIDs, Acetaminophen, or another analgesic agent on a regular basis (greater than or equal to three days per week) for at least six months before the screening visit
•OA confirmed by radiographs and diagnosed according to ACR diagnostic Criteria (clinical and radiological) for the osteoarthritis of the knee(s)
•Subjects may take tab paracetamol (Less than of equal to 2g per day) for breakthrough pain
•Subjects not having knee joint deformity
•Subjects signing written informed consent and ready to comply with the protocol requirements
•Subjects with pain VAS reater than 40 mm on weight bearing activities
ExclusionCriteria
Details
• Rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease
• History of surgery, including arthroscopy, or major trauma to the study joint in the previous six months before the screening visit
• Subjects requiring knee arthroplasty within 6 months of screening or anticipating any need for a surgical procedure on the index joint during the study
• 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
• Use of any analgesics except the study medication or paracetamol;
• Use of systemic corticosteroids within 2 months of screening, or intra-articular viscosupplementation within the past 3 months
• Use of any other investigational drug within 1 month prior to randomization;
• Subjects having diabetes mellitus, tuberculosis, HIV, Ischemic Heart Disease
• Known other major medical or surgical disease;
• Pregnancy & Lactation.
• Known hypersensitivity to ingredients used in study drug.
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
1). Knee Joint Pain on VAS
2). WOMAC Index
28 days
Secondary Outcome
Outcome
TimePoints
1). Quality of life on SF -36 questionnaire
2). Global assessment for overall improvement by the subject himself/herself at the end of 28 days of study treatment.
3). Global assessment for overall improvement by the investigator at the end of 28 days of study treatment
4). Onset and Duration of action of drugs
5). Cooling, counter irritation and warmness effects
6). tolerability of the study drugs evaluated by number of Adverse Drug Reactions
28 days
Target Sample Size
Total Sample Size="210" Sample Size from India="210" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)=""
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
On screening visit, a written informed consent will be taken from subjects for their participation in the study. Subject will undergo investigations RA Test, Serum Uric Acid and X-Ray images (Anterioposterior view and Lateral view) of Index/selected knee.
A wash out period of 3 days will be given. During washout period and the whole study period (viz. 28 days + 3 days), subject will be advised to refrain from NSAID’S or any other local or systemic analgesics except tab Paracetamol (up to 2 gm/day in case of severe joint pain).
On baseline visit (Day 0), subjects will be recruited in the study if he/she meets all the inclusion criteria. Subjects will then undergo general and systemic examinations. Subject’s baseline knee joint(s) pain will be assessed on Visual Analogue Scale (VAS), subjects joint pain subscore, stiffness subscore and physical function subscore will be assessed on WOMAC Index; the knee(s) will be evaluated for soft tissue swelling/synovitis (grade: 0= None, 1= Mild, 2=Moderate, 3=Severe.) All the subjects will be evaluated for their quality of life on SF -36 questionnaires.
After the baseline visit, subjects will be called at
1)R. A. Podar Medical (Ay) college Worli, Mumbai 18,
2) Dept. of Kayachikitsa, PDEA’s College of Ayurveda & Research Center, Sector 25, Pradhikaran, Nigadi, Pune 411044and
3) Ayurved Research Department, Ayurved Seva Sangh,Ganeshwadi, Panchvati, Nashik – 422003 for 4 follow up visits on 7th day, 14th day, 21st day, and 28th day of the treatment.
At baseline visit and at every follow up visit except the last follow up visit. As per computer generated randomization list each subject will be provided either investigational product or comparator product to be used for 7 days duration. Additional medicine of 2 days will also be provided in case if follow up is delayed, maximum upto 2 days. Patients will be advised to apply sufficient quantity of given product on the affected knee(s) joint and massage gently twice daily for 4 weeks.
On every follow up visit, subjects will undergo general and systemic examinations. The Knee joint(s) pain will be assessed on Visual Analogue Scale (VAS); subject’s knee joint(s) pain subscore, stiffness subscore and physical function subscore will be assessed by WOMAC Index; the knee(s) will be evaluated for soft tissue swelling/synovitis. Patient’s global evaluation and Investigator’s global evaluation for overall improvement will be done on every follow up visit. On every follow up visit, all the subjects will be evaluated for their quality of life on SF -36 questionnaires. Also cooling, counter irritation and warmness effects will be evaluated at each follow up visit.Tolerability of the trial medicine will be assessed by the investigator and the subject at the end of the 28 days of the treatment. Drug compliance will also be assessed by the investigator on every visit starting from first follow up visit till the completion of the trial. All the subjects will closely be monitored for any possible adverse events/ adverse drug reactions.