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

• ClinicalTrials.gov Identifier: NCT03262792
• Recruitment Status: Completed
• First Posted: August 25, 2017
• Last Update Posted: July 15, 2021
• Sponsor: Vedic Lifesciences Pvt. Ltd.
• Information provided by (Responsible Party): Vedic Lifesciences Pvt. Ltd.

Tracking Information

• First Submitted Date: August 23, 2017
• First Posted Date: August 25, 2017
• Last Update Posted Date: July 15, 2021
• Actual Study Start Date: December 13, 2017
• Actual Primary Completion Date: July 30, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 23, 2017)

WOMAC pain score [ Time Frame: 84 days ]

Change in WOMAC pain score

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessment of the Efficacy of Andrographis Paniculata in Subjects With Mild to Moderate Osteoarthritis
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

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: Knee Osteoarthritis

Intervention

• Dietary Supplement: Placebo
  Microcrystalline cellulose
• Dietary Supplement: Andrographis Paniculata
  Andrographis Paniculata 150 mg
• Dietary Supplement: Andrographis Paniculata
  Andrographis Paniculata 300 mg

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 23, 2017): 108
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 27, 2018
• Actual Primary Completion Date: July 30, 2018 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT03262792
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Vedic Lifesciences Pvt. Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Vedic Lifesciences Pvt. Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Shalini Srivastava, MD; Vedic Lifesciences

• PRS Account: Vedic Lifesciences Pvt. Ltd.
• Verification Date: July 2021