| CTRI Number |
CTRI/2024/06/069519 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial of herbal products in the management of knee osteoarthritis |
|
Scientific Title of Study
|
Clinical study to assess the efficacy & safety of celery extract capsules in the management of knee osteoarthritis. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/24-25/007 Version: 1.00; dated 18 May 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Narendra Vaidya |
| Designation |
Director |
| Affiliation |
Lokmanya Medical Research Centre and Hospital |
| Address |
Fourth floor OPD 401 314 B Telco Road Chinchwad
Pune
MAHARASHTRA
411033
India |
| Phone |
9822057766 |
| Fax |
- |
| Email |
drnarendravaidya490@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Anirudh Mehta |
| Designation |
Director |
| Affiliation |
Phytoveda Pvt. Ltd |
| Address |
6/10 Jogani Industrial Complex, N. Purav Marg, Chunabhatti
Mumbai
MAHARASHTRA
40022
India |
| Phone |
9820031562 |
| Fax |
- |
| Email |
adme@phytoveda.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Anirudh Mehta |
| Designation |
Director |
| Affiliation |
Phytoveda Pvt. Ltd |
| Address |
6/10 Jogani Industrial Complex, N. Purav Marg, Chunabhatti
Mumbai
MAHARASHTRA
40022
India |
| Phone |
9820031562 |
| Fax |
- |
| Email |
adme@phytoveda.in |
|
|
Source of Monetary or Material Support
|
| Phytoveda Pvt. Ltd. 6/10 Jogani Industrial Complex, N. Purav Marg, Chunabhatti, Mumbai-40022 |
|
|
Primary Sponsor
|
| Name |
Phytoveda Pvt Ltd |
| Address |
6/10 Jogani Industrial Complex, N. Purav Marg, Chunabhatti,
Mumbai-40022 |
| Type of Sponsor |
Other [Nutraceutical Industry] |
|
|
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 Ramshyam Agarwal |
Lokmanya Medical Research Centre and Hospital |
4th Floor OPD 401 314
B Telco Road
Chinchwad
Pune
MAHARASHTRA |
8087282022
-
ramshyam.research@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lokmanya Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Celery seed extract capsule |
One 250 mg twice daily for 90 days |
| Comparator Agent |
NA |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults aged 40 to 65 years (both inclusive), of both sexes, with a Body Mass Index (BMI) not more than 30.00 kg/m²; 2.Confirmed diagnosis of knee osteoarthritis as per clinical ACR (American College of Rheumatology) criteria – Clinical OA of the knee is defined as knee pain and at least three out of six of the following criteria: age more than 50 years old, morning stiffness less than 30 minutes, crepitus on knee motion, bony tenderness, bony enlargement, no palpable warmth; 3.Participants with a minimum pain visual analog scale (VAS) score more than 4 on walking in one or both knees during the 24 hrs. preceding recruitment; 4.Participant ambulant and requiring treatment with an anti inflammatory drug and not receiving regular anti inflammatory or analgesic drugs or not satisfied with drugs being taken and seek a change; 5.Participants taking analgesics ready for the washout period of at least 3 days (or longer depending on the pharmacokinetic of drug) before starting the study intervention; 6.Participants willing to come for regular follow up visits; 7.Participants can walk and give both verbal and written information regarding the study. |
|
| ExclusionCriteria |
| Details |
1.Known history of hypersensitivity to herbal extracts or dietary supplements;
2.Pregnant women, lactating women, and women of child bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test;
3.Non degenerative joint diseases or other joint degenerative diseases (musculoskeletal disorders) which will interfere with the evaluation of OA (Rheumatoid arthritis, active gout, recent joint trauma (target joint), or joint infection);
4.Participants incapacitated or bound to wheelchair or bed and unable to carry out self-care activities;
5.Treatment with intra-articular injection of corticosteroids into the knee within 3 months preceding study;
6.Ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate, and colchicine;
7.Evidence of several renal, hepatic, or hematopoietic disease or severe cardiac insufficiency as revealed by laboratory investigations;
8.Participant with congestive heart failure;
9.Ayurvedic formulation or any form of CAM (Complimentary Alternative Medicine) therapy in the preceding 2 months;
10.Administration of intra-articular steroids in the past 3 months or hyaluronic acid in the last 9 months;
11.Indication of surgery for OA knee;
12.Arthroscopy of either knee in the past year;
13.Any condition that in the opinion of the investigator does not justify the participant’s inclusion for the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.WOMAC A, B and C subscale scores for pain, stiffness and physical disability.
•WOMAC-A is assessed by a Likert scale on a range from 0 (none) to 4 (extreme), with higher scores indicating higher levels of pain,
•WOMAC- B for levels of stiffness and
•WOMAC-C for levels of physical disability
2.Physicians Global Assessment for pain.
3.Distance covered in six minute walk test.
4.VAS pain scale score.
5.Radiological examination - X-ray of knee (for participants as per investigators discretion. |
1.At baseline, day 15, day 30, day 60, and day 90.
2.At day 15, day 30, day 60, and day 90. 3.At baseline, day 15, day 30, day 60, and day 90.
4.At screening, baseline, day 15, day 30, day 60, and day 90. 5.At baseline and day 90. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Biomarkers such as serum PIIANP, Human Procollagen 2 C terminal Peptide, Cartilage Oligomeric Matrix Protein, C Telopeptide of type II collagen (CTX II), TNF Alpha, IL 1, IL 6, IL 7, hsCRP, MMPs (MMP 3) and urinary CTX II.
2.Requirement of analgesic as a rescue medication 3.Changes in gastrointestinal symptoms like heartburn, gastric discomfort, epigastric pain on 4 point Linkert scale 4.KOOS scoring for quality of life. 5.FACIT-F score.
6.Symptom grading on a 4 point Linkert scale for joint swelling, tenderness, and warmth. |
1.At baseline and day 90. 2.At baseline, day 15, day 30, day 60 and day 90. 3.At baseline, day 15, day 30, day 60, and day 90. 4.At baseline and day 90. 5.At baseline and day 90. 6.At baseline, day 15, day 30, day 60 and day 90. |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
05/06/2025 |
| 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="0"
Months="6"
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
|
OA is a highly prevalent chronic joint disease that leads
to significant pain, disability, and loss of function, particularly in the
knees. Pharmacological treatments for OA primarily focus on symptom relief and
often come with adverse effects, such as gastrointestinal and cardiovascular
issues. There is a growing need for safer, more effective treatments that not
only alleviate symptoms but also address the underlying pathophysiology of OA.
Celery seed extract has shown potential anti-inflammatory
and analgesic properties, making it a promising candidate for OA management.
However, there is limited clinical evidence supporting its efficacy and safety
in treating knee OA. This pilot study aims to fill this gap by evaluating the
effects of celery seed extract capsules on pain, stiffness, and mobility in participants
with knee OA over a 90-day period.
The study’s design includes comprehensive assessments of
both primary and secondary endpoints. These include changes in WOMAC scores,
VAS pain scale, six-minute walk test, inflammatory biomarkers, and reliance on
analgesics. Additionally, safety will be rigorously monitored through adverse
event profiling and hematological and biochemical evaluations.
The results could offer a new, natural therapeutic option
for OA patients, potentially improving their quality of life while minimizing
the risks associated with conventional treatments. |