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

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Andrographis Paniculata; Dietary supplement: Andrographis Paniculata

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
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400031
      • Nidaan Hospital, A/1, Adinath Society, Near Dosti Estate, Opposite Antop Hill Post Office, Wadala(West)
    • Mumbai, Maharashtra, India, 400067
      • Ayush nursing Home, Gaurav vista, Gaurav Garden,BunderpakhadiRoad, Kandivali(West)
    • Mumbai, Maharashtra, India, 400706
      • Siddhant Clinic, Shop No. 17, Lenyadri Cooperative Housing Society, Sector 19A, Nerul(East),Navi Mumbai -400706, Maharashtra
    • Mumbai, Maharashtra, India
      • Orthopaedic Clinic, 213, 2nd floor, Shiv Centre, Plot no. 72, Sector-17, Vashi, Navi Mumbai.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Microcrystalline cellulose	Dietary supplement: Placebo; Microcrystalline cellulose
Active Comparator: Andrographis Paniculata 150; Andrographis Paniculata 150 mg	Dietary supplement: Andrographis Paniculata; Andrographis Paniculata 150 mg; Dietary supplement: Andrographis Paniculata; Andrographis Paniculata 300 mg
Active Comparator: Andrographis Paniculata 300; Andrographis Paniculata 300 mg	Dietary supplement: Andrographis Paniculata; Andrographis Paniculata 150 mg; Dietary supplement: Andrographis Paniculata; Andrographis Paniculata 300 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WOMAC pain score	Change in WOMAC pain score	84 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WOMAC stiffness score	Change in WOMAC stiffness score	84 days
WOMAC physical function score	Change in WOMAC physical function score	84 days
SF-36	Change in SF-36's various component scores.	84 days
FACIT score	Change in FACIT score	84 days
Rescue medication consumption	Change in rescue medication consumption.	84 days

Collaborators and Investigators

• Sponsor: Vedic Lifesciences Pvt. Ltd.
• Investigators: Study Director: Shalini Srivastava, MD, Vedic Lifesciences

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2017
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): August 27, 2018

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 25, 2017

Study Record Updates

• Last Update Posted (Actual): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Platelet Aggregation Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Andrographolide
• Other Study ID Numbers: VL/170105/PA/OA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No