| CTRI Number |
CTRI/2025/03/081512 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical trail on joint health problems |
Scientific Title of Study
Modification(s)
|
A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Boswellia Serrata for the treatment of Knee Osteoarthritis in Male and Female Volunteers. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RRS/CL/BS/Joint Health/2024 Version: 1.0 Date: 17 Oct 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt Ltd |
| Address |
Radiant Research Services Pvt Ltd.
NO.99/A, 8th Main Road, 3rd Phase,
Peenya Industrial Area, Bengaluru-560 068
Karnataka, India.
Bangalore
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt Ltd |
| Address |
Radiant Research Services Pvt Ltd.
NO.99/A, 8th Main Road, 3rd Phase,
Peenya Industrial Area, Bengaluru-560 068
Karnataka, India.
Bangalore
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt Ltd |
| Address |
Radiant Research Services Pvt Ltd.
NO.99/A, 8th Main Road, 3rd Phase,
Peenya Industrial Area, Bengaluru-560 068
Karnataka, India.
Bangalore
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ingex Botanicals Private Limited |
|
|
Primary Sponsor
|
| Name |
Ingex Botanicals Private Limited |
| Address |
No.508, Medini, 60 ft road
F Block, Sahakaranagar, Bengaluru-560092,
Karnataka, India. |
| Type of Sponsor |
Other [ [Nutraceutical supplement company]] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Bio Actives Japan KK |
4-1-1, BAJ Bldg., Minami-Nagasaki, Toshima-Ku, Tokyo, JAPAN -171-0052 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manju Adithya Nayak Sreenivas |
Medastar Speciality Hospital |
Medstar Speciality Hospital,641/17/1/3,
Kodigehalli Main Road, Sahakar Nagar,
Bangalore-560092, Karanataka, India
Bangalore
KARNATAKA |
9035302352
dradithyamedstar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Medstar Speciality Hospital Ethics Committee |
Approved |
| Medstar Speciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Boswellia Extract |
Dose:300mg Dosage form: Capsule frequency:One capsule orally in the morning before breakfast and one capsule before lunch in the afternoon : Duration 90 days |
| Comparator Agent |
Starch |
Dose:300mg Dosage form: Capsule frequency:One capsule orally in the morning before breakfast and one capsule before lunch in the afternoon:duration 90days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Ambulatory, male and female subjects 40-75 years of age.
2.KL (Kellgren-Lawrence) grade of 1 to 2.
3.At least 30 on 100 mm visual analogue scale.
4.Subjects who had mild-to-moderate pain in knee joint upon
completion of 30 sec Chair Stand Test or 80 meter Fast-Paced Walk
Test, and otherwise no knee pain at rest.
5.Subjects who were willing to refrain from taking Ibuprofen, Aspirin
or other NSAIDs or any other pain reliever (OTC or prescription)
during the entire trial.
6.Subjects who were willing to sign the informed consent and comply
with study procedure. |
|
| ExclusionCriteria |
| Details |
1. Subjects with any possible signs indication history of arthritis, joint disorders including dislocations and quadriceps tendons tear.
2. Subjects with history of underlying inflammatory arthropathy or severe RA or OA.
3. Subjects who had used any immunosuppressive drugs in the last 6 months including steroids or biologics and those with history of immune system and autoimmune disorders.
4. Subjects with a history of knee or hip joint replacement surgery, or any hip or back pain which interferes with ambulation.
5. Subjects with BMI less than 18.5 or more than 30.
6. Subjects who consumed the medicines or supplements related with joint health within 30 days before screening visit.
7. Subjects who are not acceptable for the test by the judgment of PI.
8. Subjects with the history of tobacco smoking.
9. Subjects who were expecting the surgery during the study duration period.
10. Female subjects, who are pregnant, breast feeding or planning to become pregnant.
11. Subjects who were having known allergy to non-steroidal antiinflammatory drugs NSAIDs including aspirin or has a suspected hypersensitivity, allergy or sensitivity to herbal products.
12. Subjects who had any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol.
13. Subjects with history of gout.
14. Subjects who had taken corticosteroid, indomethacin, glucosamine chondroitin, within 90 days prior to the screening visit or intra-articular treatment injections with corticosteroid or hyaluronic acid within 90
days preceding the screening visit.
15. Subjects with the history of congestive heart failure or any vascular conditions.
16. Subjects with the evidence or history of clinically significant in the judgment of the Investigator hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic or neurologic diseases, or malignancies, hypothyroidism.
17. Subjects with history of systemic lupus erythematous SLE.
18. Subjects with history of high alcohol intake 2 standard drinks per day.
19. Subjects with history of any psychiatric disorders that may impair the ability of subjects to provide written informed consent.
20. Subjects who had participated in any other trials involving investigational or marketed products within 90 days prior to the screening visit.
21. Subjects who are currently or within 30 days prior to the screening visit on prescription or OTC medications pain relievers such as Acetaminophen Paracetamol, Ibuprofen, Aspirin or other NSAIDs r any natural health product, excluding vitamins.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Endpoints:
1.Change in WOMAC total score
2.Change in WOMAC sub-score-pain, stiffness, physical function
3.Pain VAS
4.Change in Knee injury and Osteoarthritis Outcome Score (KOOS) |
Day 0 to day30, day60 and Day90. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Endpoints:
1. Change in IL-6
2.Change in TNF-alpha levels
3.Change in C-Reactive Protein levels |
day 0 and day 90 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
13/03/2025 |
| Date of Study Completion (India) |
22/11/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Knee arthritis is a chronic, painful illness characterized by atrophy and bone loss cartilage, resulting in bone damage and subsequent bone increased incidence or "remodeling." These improvements gradually contribute to joint discomfort and swelling, followed by tenderness, weakness and restriction or lack of mobility [4]. In addition to the typical symptoms of joint pain, stiffness, and reduced range of motion, some individuals with KA also experience neuropathic pain (NP). NP arises from nerve sensitization and altered pain processing mechanisms, resulting in heightened pain sensations, increased sensitivity, and abnormal sensations like tingling or burning [5]. It is the clinical and pathological outcome of a sequence of disorders that leads to structural and functional non-performance of synovial joints.1 Usually, KA increases slowly, typically in the middle-aged to elderly people. The cartilage between the bones in the joint breaks down, which causes the affected bones to slowly get bigger. The joint cartilage often breaks down due to mechanical stress or biochemical changes in the body, resulting the bone underneath to fail. OA can occur in conjunction with other types of arthritis such as gout or rheumatoid arthritis. The risk of developing OA increases dramatically with age, and it is more frequent in females compared to males. Almost, 45% of females show symptoms and 70% of them have the radiological evidence [6].Osteoarthritis (OA) is a degenerative joint condition brought on by cartilage loss and is the most common form of arthritis. OA can affect any joint in the body but occurs most often in the knees. There are typically four stages of osteoarthritis. There is inter-individual variance on how long it takes for the OA to progress. It can take anywhere from several months to several years to reach an advanced stage of OA. Staging of OA and subsequent treatment plan is based on clinical symptoms, x-rays, blood tests, and other laboratory tests.[3] Osteoarthritis is typically staged using various classification systems to assess the severity of the condition. One commonly used system is the Kellgren-Lawrence grading scale, which assigns a grade from 0 to 4 |