| CTRI Number |
CTRI/2020/04/024918 [Registered on: 29/04/2020] Trial Registered Prospectively |
| Last Modified On: |
08/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Comparative clinical Study to Evaluate the Efficacy and Safety of “Herbal Extract
(Bonfend Tablets)†to prevent Steroid Induced Osteoporotic Changes in Patients with Rheumatoid Arthritis. |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo Controlled, Comparative
Study to Evaluate the Efficacy and Safety of “Herbal Extract
(Bonfend Tablets)†to prevent Steroid Induced Osteoporotic
Changes in Patients with Rheumatoid Arthritis. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| COD/PHZ/2019/001 Version 2.0 dated 23rd Nov 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sharad Purohit |
| Designation |
Principal Investigator |
| Affiliation |
Sanjivani Super Speciality Hospital |
| Address |
Department of Rheumatology, Ground Floor, I, New Uday Park Society. Near Sunrise Park,
Vastrapur, Ahmedabad-380015
Ahmadabad
GUJARAT
380015
India |
| Phone |
|
| Fax |
|
| Email |
dr_sharadpurohit@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Sawhney |
| Designation |
Chief Executive Officer |
| Affiliation |
COD Research Pvt Ltd |
| Address |
Medical Affairs Division, 301, I square, near Shukan Mall Cross Road, Sola, Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380060
India |
| Phone |
|
| Fax |
|
| Email |
drdeepak.s@cod-research.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Nimesh Parekh |
| Designation |
Chief Operating Officer |
| Affiliation |
COD Research Pvt Ltd |
| Address |
Department of Global Clinical Operation, 301, I square, near Shukan Mall Cross Road, Sola, Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380060
India |
| Phone |
|
| Fax |
|
| Email |
nimesh.p@cod-research.com |
|
|
Source of Monetary or Material Support
|
| Pharmanza herbal Pvt. Ltd,Plot No. 214, Borsad-Tarapur Road, Near Dharmaj Cross
Road, At. Kaniya-388435 Tal. Petlad, Dist. Anand,
Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Pharmanza herbal Pvt Ltd |
| Address |
Plot No. 214, Borsad-Tarapur Road, Near Dharmaj Cross
Road, At. Kaniya-388435 Tal. Petlad, Dist. Anand,
Gujarat, India |
| 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 Sharad Purohit |
Sanjivani Super Speciality Hospital |
Department of Rheumatology, Ground Floor, 1, Uday Park Society, Nr. Sunrise Park, Vastrapur, Ahmedabad - 15.
Ahmadabad
GUJARAT |
91-9879007908
dr_sharadpurohit@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sanjivani Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M818||Other osteoporosis without currentpathological fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bonfend Tablets |
Take tablet twice a day orally with water for 60 days with steroid dosage recommended by Physician. |
| Comparator Agent |
Placebo tablets |
Take tablet twice a day orally with water for 60 days with steroid dosage recommended by Physician. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Willing and able to provide written informed consent and comply with the requirements of the study protocol.
2. Adult subjects of either gender in age group of 18 – 65 years.
3. History of rheumatoid arthritis, as defined by American College of Rheumatology (ACR) Classification 1for at least 3-6 months and who are about to be started on steroids for the first time.
4. If female and of childbearing potential, she shall have a negative pregnancy test at the time of screening and agrees to use adequate contraception throughout the study period.
5. No history of addiction to any recreational drug or drug
dependence.
|
|
| ExclusionCriteria |
| Details |
1.Hypersensitivity to any of the components of Herbal Tablet or the excipients of the formulation.
2.Current treatment with NSAID, DMARD (the investigator for
his opinion) or any tumor necrosis factor (TNF) inhibitors or
other anti-arthritic therapy within 2 weeks prior to
randomization.
3. Major surgical procedure within 28 days prior to randomization.
4.Difficulty in swallowing and retaining oral formulation.
5. Any condition that in opinion of the Investigator, does not justify
the subjects’ participation in the study.
6.Patients with significant systemic manifestation of RA.
7.Female nursing patients.
8.Rheumatic autoimmune disease other than RA.
9.History of diagnosis of juvenile idiopathic arthritis (JIA) (also
known as juvenile rheumatoid arthritis [JRA]) and/or RA before
age 16.
10.History of inflammatory arthritis other than RA (e.g.
Inflammatory bowel disease (IBD), systemic lupus
erythematosus (SLE) or psoriatic arthritis).
11.Functional Class IV as defined by the American College of
Rheumatology (ACR) classification of functional status in RA2.
12.Use of intra-articular or parenteral corticosteroids within 4
weeks prior to screening visit. Inhaled corticosteroids for stable
medical conditions are allowed.
13.Receipt of vaccine within 4 weeks prior to enrollment visit.
14.History of primary or secondary immunodeficiency.
Evidence of significant uncontrolled concomitant diseases such
as cardiovascular disease, nervous system, renal, hepatic,
endocrine, gastrointestinal, or pulmonary disease, including any
pulmonary or other condition that would preclude subject
participation.
15.Known active bacterial, viral, fungal, mycobacterial, or other
infection (including tuberculosis or atypical mycobacterial
disease but excluding fungal infections of nail beds).
16.History of travel to areas endemic for mycoses, such as
histoplasmosis, coccidioidomycosis or blastomycosis
17.History of recurrent significant infection or any significant
episode of infection requiring hospitalization or treatment with
IV antibiotics within 4 weeks of screening oral antibiotics within
2 weeks prior to screening
18.History of cancer, including solid tumors and hematologic
malignancies (except basal cell and squamous cell carcinoma of
the skin that have been excised and cured).
19. Lack of peripheral venous access.
20.History of chronic daily use of narcotic analgesics.
21.History of alcohol, drug, or chemical abuse within 6 months
prior to screening.
22.Positive history of Hepatitis B surface antigen or antibodies to
Hepatitis C.
23.History of significant cytopenia’s or other bone marrow
disorder.
24.Laboratory exclusion criteria: Patients may not participate in this
study until any of the following that are present have resolved.
a. Serum creatinine > 1.4 mg/dL for women or 1.6 mg/dL for
men.
b. AST or ALT > 2.5 times upper limit of normal (UNL)
c. Neutrophil < 1.5 x 103/μL
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in lumbar spine BMD compared between Herbal
Tablet and Placebo from baseline at the end of 2 months.
Change in DAS 28-ESR compared between Herbal Tablet and
Placebo from baseline at the end of 2 months (Appendix C).
Change in Bone Specific Alkaline Phosphate (BSAP), P1NP
(Procollagen Type 1 N-Terminal Propeptide), Rheumatoid
Factor and C-reactive protein (CRP) compared between
Herbal Tablet and Placebo from baseline at the end of 2
months. |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in tenderness compared between Herbal Tablet and
Placebo using VAS score from baseline at the end of 2 months.
(Appendix D).
Change in swollen joint counts compared between Herbal
Tablet and Placebo using VAS score from baseline at the end
of 2 months (Appendix D).
Change in pain scale compared between Herbal Tablet and
Placebo using VAS score from baseline at the end of 2 months
(Appendix D).
Treatment emergent AE or SAE
|
2 months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Osteoporosis and its main complication, fragility fractures, incur substantial global morbidity and
mortality. Glucocorticoids are important therapeutic agents that have been used for their potent antiinflammatory and immunosuppressive properties for over 50 years in patients of RA. Pharmanza Herbal has developed an Ayurvedic Proprietary Medicine. Hence, to test this hypothesis,
a study titled “A Randomized, Double Blind, Placebo Controlled, Comparative Study to Evaluate the
Efficacy and Safety of “Herbal Extract (Bonfend Tablets)†to prevent Steroid Induced Osteoporotic
Changes in Patients with Rheumatoid Arthritis†is planned. |