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Assessment of the Efficacy of Andrographis Paniculata in Subjects With Mild to Moderate Osteoarthritis (A Paniculata)

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 : July 15, 2021
Sponsor:
Information provided by (Responsible Party):
Vedic Lifesciences Pvt. Ltd.

Tracking Information
First Submitted Date  ICMJE August 23, 2017
First Posted Date  ICMJE August 25, 2017
Last Update Posted Date July 15, 2021
Actual Study Start Date  ICMJE December 13, 2017
Actual Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2017)
WOMAC pain score [ Time Frame: 84 days ]
Change in WOMAC pain score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2017)
  • WOMAC stiffness score [ Time Frame: 84 days ]
    Change in WOMAC stiffness score
  • WOMAC physical function score [ Time Frame: 84 days ]
    Change in WOMAC physical function score
  • SF-36 [ Time Frame: 84 days ]
    Change in SF-36's various component scores.
  • FACIT score [ Time Frame: 84 days ]
    Change in FACIT score
  • Rescue medication consumption [ Time Frame: 84 days ]
    Change in rescue medication consumption.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Efficacy of Andrographis Paniculata in Subjects With Mild to Moderate Osteoarthritis
Official Title  ICMJE A Double-blind, Randomized, Placebo Controlled Study to Assess the Efficacy of Andrographis Paniculata in Subjects With Mild to Moderate Osteoarthritis Over a 12-weeks Period
Brief Summary This is a 12 weeks randomized, double-blind, placebo-controlled clinical study to assess the effect of Andrographis Paniculata 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.
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 Andrographis Paniculata on liver and kidneys.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Dietary Supplement: Placebo
    Microcrystalline cellulose
  • Dietary Supplement: Andrographis Paniculata
    Andrographis Paniculata 150 mg
  • Dietary Supplement: Andrographis Paniculata
    Andrographis Paniculata 300 mg
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Microcrystalline cellulose
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: Andrographis Paniculata 150
    Andrographis Paniculata 150 mg
    Intervention: Dietary Supplement: Andrographis Paniculata
  • Active Comparator: Andrographis Paniculata 300
    Andrographis Paniculata 300 mg
    Intervention: Dietary Supplement: Andrographis Paniculata
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 23, 2017)
108
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 27, 2018
Actual Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03262792
Other Study ID Numbers  ICMJE VL/170105/PA/OA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Vedic Lifesciences Pvt. Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Vedic Lifesciences Pvt. Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Shalini Srivastava, MD Vedic Lifesciences
PRS Account Vedic Lifesciences Pvt. Ltd.
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP