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Assessment of the Efficacy of ParActin® in Subjects With Mild to Moderate Osteoarthritis (ParActin)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03262792
Recruitment Status : Completed
First Posted : August 25, 2017
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Vedic Lifesciences Pvt. Ltd.

Brief Summary:
This is a 12 weeks randomized, double-blind, placebo-controlled clinical study to assess the effect of ParActin® at low dose of 300 mg/day and high dose of 600 mg/day in the study population in the age range of 40-70 years and suffering from mild-moderate OA.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Dietary Supplement: Placebo Dietary Supplement: ParActin Not Applicable

Detailed Description:

In this study, we will assess the efficacy parameters such as effect on various joint health parameters (pain, stiffness and physical activity) by using WOMAC scale. The individuals with knee OA suffer from an increased impact on their activities of daily living, which leads to losses in labor relations, leisure, social life, and sleeping quality, leading also to important decrease in their quality of life. Thus, an important outcome to be evaluated in this study is quality of life of these individuals which will be assessed by SF-36 self-reported questionnaire. One of the aims of this study is therefore to investigate the levels of different dimensions of fatigue in knee OA and to assess changes in fatigue after the treatment targeting pain reduction and physical functioning by the use of FACIT-fatigue questionnaire.

Effect of the treatment on rescue medication consumption which is directly proportional to the degree of pain will also be captured via this study. The hepatic (SGOT and SGPT) and renal (serum creatinine) safety biomarkers will be assessed to investigate the effect of chronic use of ParActin® on liver and kidneys.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo controlled, parallel groups study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo Controlled Study to Assess the Efficacy of ParActin® in Subjects With Mild to Moderate Osteoarthritis Over a 12-weeks Period
Actual Study Start Date : December 13, 2017
Actual Primary Completion Date : July 30, 2018
Actual Study Completion Date : August 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Placebo Comparator: Placebo
Microcrystalline cellulose
Dietary Supplement: Placebo
Microcrystalline cellulose

Active Comparator: ParActin 150
ParActin 150 mg
Dietary Supplement: ParActin
ParActin 150 mg

Active Comparator: ParActin 300
ParActin 300 mg
Dietary Supplement: ParActin
ParActin 300 mg




Primary Outcome Measures :
  1. WOMAC pain score [ Time Frame: 84 days ]
    Change in WOMAC pain score


Secondary Outcome Measures :
  1. WOMAC stiffness score [ Time Frame: 84 days ]
    Change in WOMAC stiffness score

  2. WOMAC physical function score [ Time Frame: 84 days ]
    Change in WOMAC physical function score

  3. SF-36 [ Time Frame: 84 days ]
    Change in SF-36's various component scores.

  4. FACIT score [ Time Frame: 84 days ]
    Change in FACIT score

  5. Rescue medication consumption [ Time Frame: 84 days ]
    Change in rescue medication consumption.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects in the age range of 40 - 70 years (both inclusive).
  2. Body mass index (BMI) must be ≥ 25 and < 29.9 kg/m2.
  3. Radiographic evidence of grade I- II osteoarthritis of knee joint, based on the Kellgren and Lawrence radiographic entry criteria with WOMAC pain score in range of 10-16.
  4. History of primary idiopathic osteoarthritis of the knee characterized by pain of mild to moderate intensity which requires intake of analgesics.
  5. Self-reported difficulty in at least one of the following activities attributed to knee pain: walking a distance of 400 metres, getting in and out of the car, going up and down the stairs or stiffness observed in the knee if > 30 minutes in the same position.
  6. Female subjects of child-bearing age must be willing to use the accepted methods of contraception during the course of the study.
  7. Ability to provide written informed consent.

Exclusion Criteria:

  1. Prior or ongoing medical conditions (e.g. concomitant illness, psychiatric condition, alcoholism, drug abuse), medical history, physical findings, ECG findings or laboratory abnormalities that in the investigator's opinion could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow-up would be completed or could impair the assessment of study results.
  2. History of surgery or major trauma to the study joint.
  3. History of arthroscopic surgery or intervention on the study joint.
  4. Subjects who have received intra-articular steroids or hyaluronic acid within the last three months.
  5. Signs of active study joint inflammation including redness, warmth, and/or, if qualifying with osteoarthritis of the knee, a large, bulging effusion of the study knee joint with the loss of normal contour of the joint at the screening visit or at the baseline examination after the washout period.
  6. Subjects awaiting a replacement of knee or hip joint.
  7. Subjects with other conditions that cause pain.
  8. Subjects with deformity of the knee joint.
  9. Subject who are significantly incapacitated or disabled and would be categorized as ACR Functional Class IV (largely or wholly incapacitated), or unable to walk without assistive devices.
  10. Subjects with other known rheumatic or inflammatory disease such as rheumatoid arthritis, osteomyelitis and bone metastasis.
  11. Other pathologic lesions on X-rays of knee.
  12. Positive hepatitis B surface antigen, Hepatitis C antibody, Anti human immunodeficiency virus (HIV) antibody test, or VDRL.
  13. History of bleeding disorders.
  14. Inability to comply with the protocol requirements.
  15. Participation in any other clinical trial within 3 months of registering in this trial.
  16. Women of child-bearing potential with a positive pregnancy test or who are lactating.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262792


Locations
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India
Nidaan Hospital, A/1, Adinath Society, Near Dosti Estate, Opposite Antop Hill Post Office, Wadala(West)
Mumbai, Maharashtra, India, 400031
Ayush nursing Home, Gaurav vista, Gaurav Garden,BunderpakhadiRoad, Kandivali(West)
Mumbai, Maharashtra, India, 400067
Siddhant Clinic, Shop No. 17, Lenyadri Cooperative Housing Society, Sector 19A, Nerul(East),Navi Mumbai -400706, Maharashtra
Mumbai, Maharashtra, India, 400706
Orthopaedic Clinic, 213, 2nd floor, Shiv Centre, Plot no. 72, Sector-17, Vashi, Navi Mumbai.
Mumbai, Maharashtra, India
Sponsors and Collaborators
Vedic Lifesciences Pvt. Ltd.
Investigators
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Study Director: Shalini Srivastava, MD Vedic Lifesciences
Additional Information:
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Responsible Party: Vedic Lifesciences Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT03262792    
Other Study ID Numbers: VL/170105/PA/OA
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases