| CTRI Number |
CTRI/2020/02/023475 [Registered on: 20/02/2020] Trial Registered Prospectively |
| Last Modified On: |
23/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Herbal formulation clinical trial on Joint Health in audults |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled clinical study to evaluate comparative clinical Efficacy and Safety of BHC9619CP Turmeric extractin Joint Health |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BH/JH/19/01 Version no 1.0 dated 18th Dec 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MrManjunath |
| Designation |
Head of clinical operation |
| Affiliation |
Bangalore clinical services |
| Address |
Bangalore clinical services
No. 265, 3rd Floor, 6th Main, 4th Cross Rd, BTM 2nd Stage, Bengaluru, Karnataka
Bangalore
KARNATAKA
560076
India |
| Phone |
|
| Fax |
|
| Email |
manjureddy01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MrManjunath |
| Designation |
Head of clinical operation |
| Affiliation |
Bangalore clinical services |
| Address |
Bangalore clinical services
No. 265, 3rd Floor, 6th Main, 4th Cross Rd, BTM 2nd Stage, Bengaluru, Karnataka
KARNATAKA
560076
India |
| Phone |
|
| Fax |
|
| Email |
manjureddy01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MrManjunath |
| Designation |
Head of clinical operation |
| Affiliation |
Bangalore clinical services |
| Address |
Bangalore clinical services
No. 265, 3rd Floor, 6th Main, 4th Cross Rd, BTM 2nd Stage, Bengaluru, Karnataka
KARNATAKA
560076
India |
| Phone |
|
| Fax |
|
| Email |
manjureddy01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Botanic Healthcare Pvt Ltd
No. 35, Mani Mansion Floor-1 Street-1 Secunderbad, Tarnaka, Hyderabad, Telangana 500017 |
|
|
Primary Sponsor
|
| Name |
Botanic Healthcare Pvt Ltd |
| Address |
No. 35, Mani Mansion Floor-1 Street-1 Secunderbad, Tarnaka, Hyderabad, Telangana 500017 |
| 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 Srinivas pandurangaiah |
Shettys Hospital |
Ground floor Room number 4
Plot No 11 and 12th F Main Road Kaveri Nagar Bommanahalli Bengaluru Karnataka 560068
Bangalore
KARNATAKA |
0825732886
shettyshospital@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shettys hospital Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M244||Recurrent dislocation of joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BHC9619CP Turmeric extractin |
Dose : 500 mg
Capsule dosage form
frequency : Three times daily after meal
Route : orally |
| Comparator Agent |
Placebo |
Dose : 500 mg
Capsule dosage form
frequency : Three times daily after meal
Route : orally |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Ambulatory, male and female subjects of 40–70 years of age with a Body Mass Index (BMI) of 20 to 29 kg/m2.
2. Subjects with VAS score between 40 and 70 mm.
3. Subjects with Knee osteoarthritis grade II to III of Kellgren and Lawrence assessed based on X-ray.
4. Willing to refrain from use of glucosamine, chondroitin, MSM, DMSO, doxycycline, ibuprofen, aspirin or other NSAIDS (other than paracetamol as rescue medication) or any other pain reliever (OTC or prescription) during the entire trial.
5. Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
6. Results of screening are within normal range or considered not clinically significant by the Principal Investigator.
7. Subjects ready to discontinue the use of supplementations including vitamins, glucosamine + chondroitin, herbals or other topical applications.
8. Agree to participate in the study through a written informed consent.
9. Willing to comply with all the study related activities.
|
|
| ExclusionCriteria |
| Details |
1.Previous injury and or surgery to the knee.
2.Expectation of surgery during the study period.
3.Subjects with uncontrolled Diabetes
4.Subjects suffering from COPD or having history of any respiratory or breathing disorders.
5.Subjects used any immunosuppressive drugs in the last 6 months including steroids or biologics and those with history of immune system and autoimmune disorders.
6.Female subjects who are pregnant breast feeding or planning to become pregnantduring the study period.
7.Subjects having known allergy to non steroidal antiinflammatory drugs NSAIDs including aspirin or has a suspected hypersensitivity allergy or sensitivity to herbal products.
8. Have taken any corticosteroid indomethacin within 1 month prior to theenrollment or intra articular treatment injections with corticosteroid or hyaluronic acid within 6 months prior to enrollment.
9.History of congestive heart failure or any vascular conditions.
10.Subjects with HIV Positive status.
11.Evidence or history of clinically significant in the judgment of the Investigator hematological renal, endocrine pulmonary gastrointestinal cardiovascular hepatic neurologic diseases or malignancies hypothyroidism.
12.History of Systemic Lupus Erythematous
13.Alcohol intake greater than 2 standard drinks per day or use of recreational drugs such as cocaine methamphetamine, marijuana, etc
14.History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
15.Participation in any other trials involving investigational or marketed products within 30days prior to the screening visit.
16.Have taken acetaminophen paracetamol, ibuprofen, aspirin or other NSAIDS or any other pain reliever (OTC or prescription) or any herbal products within 7 days prior to the screening visit
17.History of heart, liver, lung cancer or chronic diseases.
18.Allergies to any ingredient in the investigational products.
19.Any other condition that, in the opinion of the investigator would adversely affect the subjects ability to complete the study or its measures.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of turmeric in subjects with mild to moderate knee Osteoarthritis |
Day 0, Day 28 and Day 56 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the safety and tolerability of the study supplement by monitoring the vital signs and possibility of adverse events at each follow-up. |
Day 0 and Day 56 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
24/02/2020 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Osteoarthritis is a
common, chronic, progressive, skeletal, degenerative disorder, which commonly
affects the knee joint. Degenerative joint disease is the most common joint
pathology and the main cause of disability of elderly people in developed
countries.OA is characterized by articular cartilage degradation with an
accompanying periarticularbone response. OA of the knee and hip are a growing health
concern and are the most common form of arthritis Pain and disease can range from very mild to very severe. Patients with OA have
pain that typically worsens with weight bearing, including walking and standing,
and improves with rest Due to decreased movement because of the pain, regional muscles may
atrophy, and ligaments may become more lax. Other side effects include morning
stiffness and gelling of the involved joint after periods of inactivity. Severe
inflammation is not a prevalent sign ofOA, but inflammation due to the bone
outgrowths, does occur .The progression
of OA is aslow process taking years. Treatment of OA may include exercise,
heat/cold therapy, joint protection,
weight loss, physiotherapy/occupational therapy and medications . The most common
medications include acetaminophen and NSAIDs. The purpose of this study is
to evaluate the efficacy and tolerability of BHC9619CP Turmeric
extract in Joint Health
|