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

NCT03262792 | Completed

• 1 other identifier: VL/170105/PA/OA
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 4

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• WOMAC pain score

  Change in WOMAC pain score

  84 days

Secondary Outcomes (5)

• WOMAC stiffness score

  84 days

• WOMAC physical function score

  84 days

• SF-36

  84 days

• FACIT score

  84 days

• Rescue medication consumption

  84 days

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Microcrystalline cellulose

Dietary Supplement: Placebo

Andrographis Paniculata 150

ACTIVE COMPARATOR

Andrographis Paniculata 150 mg

Dietary Supplement: Andrographis Paniculata

Andrographis Paniculata 300

ACTIVE COMPARATOR

Andrographis Paniculata 300 mg

Dietary Supplement: Andrographis Paniculata

Interventions

Placebo DIETARY_SUPPLEMENT

Microcrystalline cellulose

Placebo

Andrographis Paniculata DIETARY_SUPPLEMENT

Andrographis Paniculata 150 mg

Andrographis Paniculata 150

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects in the age range of 40 - 70 years (both inclusive).
• Body mass index (BMI) must be ≥ 25 and \< 29.9 kg/m2.
• 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.
• History of primary idiopathic osteoarthritis of the knee characterized by pain of mild to moderate intensity which requires intake of analgesics.
• 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.
• Female subjects of child-bearing age must be willing to use the accepted methods of contraception during the course of the study.
• Ability to provide written informed consent.

You may not qualify if:

• 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.
• History of surgery or major trauma to the study joint.
• History of arthroscopic surgery or intervention on the study joint.
• Subjects who have received intra-articular steroids or hyaluronic acid within the last three months.
• 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.
• Subjects awaiting a replacement of knee or hip joint.
• Subjects with other conditions that cause pain.
• Subjects with deformity of the knee joint.
• 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.
• Subjects with other known rheumatic or inflammatory disease such as rheumatoid arthritis, osteomyelitis and bone metastasis.
• Other pathologic lesions on X-rays of knee.
• Positive hepatitis B surface antigen, Hepatitis C antibody, Anti human immunodeficiency virus (HIV) antibody test, or VDRL.
• History of bleeding disorders.
• Inability to comply with the protocol requirements.
• Participation in any other clinical trial within 3 months of registering in this trial.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (4)

Nidaan Hospital, A/1, Adinath Society, Near Dosti Estate, Opposite Antop Hill Post Office, Wadala(West)

Mumbai, Maharashtra, 400031, India

Location

Ayush nursing Home, Gaurav vista, Gaurav Garden,BunderpakhadiRoad, Kandivali(West)

Mumbai, Maharashtra, 400067, India

Location

Siddhant Clinic, Shop No. 17, Lenyadri Cooperative Housing Society, Sector 19A, Nerul(East),Navi Mumbai -400706, Maharashtra

Mumbai, Maharashtra, 400706, India

Location

Orthopaedic Clinic, 213, 2nd floor, Shiv Centre, Plot no. 72, Sector-17, Vashi, Navi Mumbai.

Mumbai, Maharashtra, India

Location

Related Links

• Related Info

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Andrographis paniculata extract

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Shalini Srivastava, MD

  Vedic Lifesciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo controlled, parallel groups study.

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 25, 2017
• Study Start: December 13, 2017
• Primary Completion: July 30, 2018
• Study Completion: August 27, 2018
• Last Updated: July 15, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (4)