| CTRI Number |
CTRI/2025/09/095056 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Testing How Safe and Effective Bonivia OA Tablets Are for Treating Knee Osteoarthritis: A Clinical Study |
|
Scientific Title of Study
|
EVALUATION OF THE EFFICACY AND SAFETY OF TABLET BONIVIA OA IN KNEE OSTEOARTHRITIS: A RANDOMIZED CONTROLLED CLINICAL STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr MADHAVI MAHAJAN |
| Designation |
Professor |
| Affiliation |
BVDU COLLEGE OF AYURVED AND HOSPITAL, |
| Address |
OPD no. 4, Department of Kayachikitsa,
BHARATI VIDYAPEETH COLLEGE OF AYURVEDA AND HOSPITAL, KATRAJ, PUNE
Pune
MAHARASHTRA
411043
India |
| Phone |
9860124248 |
| Fax |
|
| Email |
madhavi.mahajan@bharatividyapeeth.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MADHAVI MAHAJAN |
| Designation |
Professor |
| Affiliation |
BVDU COLLEGE OF AYURVED AND HOSPITAL, |
| Address |
OPD no. 4, Department of Kayachikitsa,
BHARATI VIDYAPEETH COLLEGE OF AYURVEDA AND HOSPITAL, KATRAJ, PUNE
Pune
MAHARASHTRA
411043
India |
| Phone |
9860124248 |
| Fax |
|
| Email |
madhavi.mahajan@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr MADHAVI MAHAJAN |
| Designation |
Professor |
| Affiliation |
BVDU COLLEGE OF AYURVED AND HOSPITAL, |
| Address |
OPD no. 4, Department of Kayachikitsa ,
BHARATI VIDYAPEETH COLLEGE OF AYURVEDA AND HOSPITAL, KATRAJ, PUNE
Pune
MAHARASHTRA
411043
India |
| Phone |
9860124248 |
| Fax |
|
| Email |
madhavi.mahajan@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SAVA Healthcare Pvt Ltd |
| Address |
K-1/702/1/C, GIDC, Phase 3, Wadhwan, Surendranagar, Gujarat 363030 |
| 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 Madhavi Mahajan |
Bharati Vidyapeeth (Deemed to be University), College of Ayurved and Hospital |
Educational Campus, Pune - Satara Rd, Bharati Vidyapeeth Campus, Dhankawadi
Pune
MAHARASHTRA |
9860124248
madhavi.mahajan@bharatividyapeeth.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee, BVDUCOA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M17||Osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Tab. Bonvia OA , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 120 Days, anupAna/sahapAna: Yes(details: -Luke warm Water ), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo Drug | 500 mg tablets of pearl millet flour will be dispensed to the comparator group.
2 placebo tablets of 500 mg twice a day after meals with lukewarm water. |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Age greater than or equal to 50 Years
Diagnosed with primary knee OA as per ACR criteria
ACR Functional Status Class I, II, or III
Willing to give informed consent
Diagnostic criteria as per ACR (American College of Rhuematology)
Knee pain plus any three of the following:
Age greater than or equal to 50 years
Morning stiffness less than 30 minutes
Crepitus
Bony tenderness
Bony enlargement
No palpable warmth
|
|
| ExclusionCriteria |
| Details |
Radiographic Grade greater than or equal to 3 OA (Kellgren-Lawrence classification)
Significant knee trauma or arthroscopy in past 1 year
History of knee joint replacement
BMI greater than or equal to 30 kg per m²
Intra-articular corticosteroids or hyaluronic acid in the last month
Use of corticosteroids in last month
History of rheumatoid arthritis, psoriatic arthritis, or any inflammatory arthritis
Liver enzymes greater than 3× normal, or serum creatinine greater than 1.2 mg%
Active or prior malignancy
Known hypersensitivity to study drugs
Any condition that may affect safety or compliance (as per the investigator’s opinion)
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in Clinical Symptoms of Knee OA
Improvement in WOMAC Index Score
Improvement in Numeric Pain Rating Scale (NPRS)
Improvement in inflammatory and degenerative markers
Improvement in health-related quality of life (SF-12)
Reduction in Rescue Analgesic use |
Follow up on Days
30th, 60th, 90th, 120th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
29/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Osteoarthritis (OA), a leading cause of disability in the aging population, is increasingly prevalent
due to rising obesity and longer life expectancy. Despite advances in OA management, regeneration
of articular cartilage in an inflammatory environment remains a major therapeutic challenge.
Current non-pharmacological measures—patient education, exercise, and weight control—remain
foundational, while pharmacological options like NSAIDs and paracetamol offer only symptomatic
relief with limited efficacy and safety concerns . No drug currently halts OA progression,
prompting the FDA in 2018 to recognize OA as a “serious disease with an unmet medical need” .
OA is now acknowledged as a multifactorial joint disease marked by inflammation, cartilage
degradation, synovitis, and subchondral bone changes. In Ayurveda, OA is described as Sandhigata Vata, a condition of
joint pain, swelling, crepitus, and restricted movement, primarily due to aggravated Vata dosha
[12]. It is classified as Vatavyadhi and is more prevalent in old age, making it Kashtasadhya
(difficult to treat). The Ministry of AYUSH, through the NAMASTE portal, recognizes OA as a
research priority for integrative care. Bonivia OA is a polyherbal Ayurvedic formulation aimed at the multidimensional pathology of OA.
Its ingredients—Ashwagandha (Withania somnifera), Guduchi (Tinospora cordifolia), Gokshura
(Tribulus terrestris), Nirgundi (Vitex negundo), Dashamoola, Shankhabhasma, and Mahayograj
Guggulu—possess anti-inflammatory, immunomodulatory, and chondroprotective actions. The formulation balances aggravated Vata using Laghu (light), Snigdha (unctuous), and Ushna
(hot) properties to counter Ruksha and Sheeta qualities. Its bitter, pungent, and astringent taste
supports Shothaghna (anti-inflammatory), Shoolaghna (analgesic), and Bruhan (nourishing) effects.
Bonivia OA thus provides a holistic, evidence-backed, and safer alternative to conventional
therapies, aligning with Ayurvedic principles while addressing modern clinical needs in OA
management. The current study focusses on efficacy of tablet Bonivia OA on knee osteoarthritis with the help of parameters like clinical symtoms, WOMAC Index Score, Numeric Pain Rating Scale, SF-12 questionnaire and inflammtory bio markers such as PGE-II, CTX, IL-6. The safety of the drug will aslo be evaulated using hematological investigations like Liver function tests, blood ureal leves and serum creatinine. |