| CTRI Number |
CTRI/2019/04/018457 [Registered on: 08/04/2019] Trial Registered Prospectively |
| Last Modified On: |
18/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study to evaluate effectiveness, safety and efficacy of Nucart VG Tablet in treatment of Osteoarthritis. |
|
Scientific Title of Study
|
An Observational, Randomized, open labelled, parallel group, two arm, study to evaluate safety and efficacy of Tab Nucart VG when compared with Glucosamine tablet in treatment of osteoarthritis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrs Pranjal Nandode |
| Designation |
Project Manager |
| Affiliation |
Ardent Clinical Research Services |
| Address |
Office No. 318, 3rd Floor, Next to Frankfin Institute, Connaught Place,
Bund Garden Road,Pune.
Pune
MAHARASHTRA
411001
India |
| Phone |
|
| Fax |
|
| Email |
pranjal@ardent-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sailee Kadam |
| Designation |
Assistant General Manager-Medical Affair |
| Affiliation |
Gufic Biosciences Ltd. |
| Address |
S. M. House,
11, Sahakar Road, Vile Parle (East),
Mumbai – 400 057 ( INDIA )
Mumbai
MAHARASHTRA
400057
India |
| Phone |
|
| Fax |
|
| Email |
herbalmed@guficbio.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Chandu Devanpally |
| Designation |
Managing Director |
| Affiliation |
Ardent Clinical Research Services |
| Address |
Office No. 318, 3rd Floor, Next to Frankfin Institute, Connaught Place,
Bund Garden Road,Pune.
Pune
MAHARASHTRA
411001
India |
| Phone |
|
| Fax |
|
| Email |
cdevanpally@ardent-cro.com |
|
|
Source of Monetary or Material Support
|
| Gufic Biosciences Ltd.
SM House, Vileparle [East], Mumbai 400 057 [India] |
|
|
Primary Sponsor
|
| Name |
Gufic Biosciences Ltd |
| Address |
S. M. House,
11, Sahakar Road, Vile Parle (East),
Mumbai – 400 057 ( INDIA ) |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijay Goni |
PGIMER |
Dept. of Orthopedic Surgery Nehru Hospital,PGIMER, Chandigarh, 160012
Ludhiana
PUNJAB |
9815712727
vijaygoni@gmail.com |
| Dr Mukesh Mishra |
Shat Aayu Multispeciality hospital |
Near hitvada Press, Wardha Road,
Nagpur -440012
Wardha
MAHARASHTRA |
9822565161
shatayuhospital@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PGIMER |
Approved |
| Jasleen hospitals ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Glucosamine |
Glucosamine Tablet [750mg]1 tablet twice daily after meals for 3 months. |
| Intervention |
Nucart VG |
Its a herbal formulation in tablet form. Composition: Each Nucart-VG tablet contains
ï‚· Boswellia serrata extract(600 mg) + Glucosamine sulphate 2KCL(750 mg)
ï¶ Dosage & Duration of therapy: 1 tablet each twice daily after meals (1 tab of Boswellia serrata + 1 tab of Glucosamine sulphate) orally for 3 months.
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to provide written informed consent and comply with study instructions for its duration.
2. Healthy male or non-pregnant female aged 45 to 65 years with a clinical symptom of Osteoarthritis.
3. Unilateral or bilateral osteoarthritis for more than 3 months
4. Symptoms for at least 6 months prior to screening.
5. Pain for 15 days of the preceding month (periarticular pain due to OA and not due to other conditions such as RA, bursitis, tendonitis, etc.).
6. Had an X-ray of the target joints taken no more than 1 year before baseline, showing evidence of OA with Kellgren-Lawrence grade 1-3 disease.
7. Females of child-bearing potential should have a negative serum pregnancy test prior to beginning therapy and agree to use adequate birth control during the study (acceptable methods include hormonal contraception maintained for a period of 3 months prior to the study and persisting through the study period, intrauterine device, barrier or abstinence). |
|
| ExclusionCriteria |
| Details |
Recent injury in the area affected by osteoarthritis of the knee (past 4 months) and expectation of surgery in the next 4 months
2. History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g.,colitis) or fibromyalgia, underlying inflammatory arthropathy or severe rheumatoid arthritis
3. Hypersensitivity to non-steroidal anti-inflammatory drugs, abnormal liver or kidney function tests, history of peptic ulceration and upper Gastrointestinal hemorrhage, congestive heart failure, hypertension, hyperkalemia.
4. History of gastrointestinal bleeding or peptic ulcer disease.
5. Intra-articular corticosteroid injections within the preceding 3 months
6. Hyperuricemia (>440 μmol/l) and/or past history of gout
7. Major abnormal findings on complete blood count, history of coagulopathies, hematological or neurological disorders8. Pregnant, breastfeeding, or planning to become pregnant during the studyObesity (body mass index > 30 kg/m2)
10. X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease.
11. Any other acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the patient at risk by participating in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean change from baseline to subsequent visits and EOT visit in the WOMAC pain score.
ï‚· An improvement in pain and physical functions by using standard tools (Visual analog scale for pain, Western Ontario & McMaster Universities Osteoarthritis Index)
Quality of life questionnaire (EQ5D) |
Mean change from Day 0 to subsequent visits and Day 90 visit in the WOMAC pain score.
ï‚· An improvement in pain and physical functions by using standard tools (Visual analog scale for pain, Western Ontario & McMaster Universities Osteoarthritis Index) at day 0 and day 90.
Quality of life questionnaire (EQ5D) at day 0 and day 90. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| All adverse events (AEs) will be reported at each visit to allow a comparison between treatment groups. |
No of events occurring from screening to end of treatment |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2019 |
| Date of Study Completion (India) |
03/07/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is designed as a multicenter, open label, observational study. Subjects will be assigned to receive either Nucart – VG Tab or Glucosamine tablet. Parameters of WOMAC pain score, VAS scale and Quality of Life questionnaires will be assessed. Safety parameters like haematology and biochemistry will be assessed. AE/SAE will be recorded during the conduct of trial.investigator will evaluate whether the patient meets all the inclusion criteria and does not meet any of the exclusion criteria, to participate in the study. After signing informed consent form to determine the eligibility, investigator will investigate about the disease history, present signs and symptoms and treatment taken in past. Demographics (Age, Gender, height, weight (screening only)) and vital signs (Pulse Rate, Respiratory Rate, temperature, BP (At all visits)) will be recorded, X-ray and will be performed at screening. Local Laboratory Investigations: Blood sample (20.0 ml) will be collected at Screening for Hematology (Complete Blood count) and Biochemistry (RA Factor, SGPT, SGOT, serum Bilirubin). Urine Pregnancy test – All females who did not reach menopause will undergo a pregnancy test in local lab. After satisfying the eligibility criteria, investigator will perform detailed physical and systemic examinations and will give Patient a test request form for laboratory investigations i.e. X-Ray, CBC, UPT, SGPT and SGOT test. Based on these investigations, investigator will decide whether the patient is eligible to participate in the study. Study Duration is 90 days. Subject will consume either 1 tablet each twice daily after meals (1 tab of Boswellia serrata + 1 tab of Glucosamine sulphate) orally for 3 months or Glucosamine Tablet [750mg]1 tablet twice daily after meals for 3 months. |