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

NCT ID: NCT03262792

Last Updated: 2021-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-13
• Study Completion Date: 2018-08-27

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Microcrystalline cellulose

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Microcrystalline cellulose

Andrographis Paniculata 150

Andrographis Paniculata 150 mg

Group Type: ACTIVE_COMPARATOR

Andrographis Paniculata

Intervention Type: DIETARY_SUPPLEMENT

Andrographis Paniculata 150 mg

Andrographis Paniculata 300

Andrographis Paniculata 300 mg

Group Type: ACTIVE_COMPARATOR

Andrographis Paniculata

Intervention Type: DIETARY_SUPPLEMENT

Andrographis Paniculata 300 mg

Interventions

Placebo

Microcrystalline cellulose

Intervention Type: DIETARY_SUPPLEMENT

Andrographis Paniculata

Andrographis Paniculata 150 mg

Intervention Type: DIETARY_SUPPLEMENT

Andrographis Paniculata

Andrographis Paniculata 300 mg

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vedic Lifesciences Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shalini Srivastava, MD

Role: STUDY_DIRECTOR

Vedic Lifesciences

Locations

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

Mumbai, Maharashtra, India

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

Mumbai, Maharashtra, India

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.

Mumbai, Maharashtra, India

Countries

India

Related Links

http://hpingredients.com/products/premier-ingredients/paractin/

Related Info

Other Identifiers

VL/170105/PA/OA

Identifier Type: -

Identifier Source: org_study_id