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

Knee Osteoarthritis Clinical Trial

— A Paniculata  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03262792
• Other study ID #: VL/170105/PA/OA
• Status: Completed
• Phase: N/A
• Start date: December 13, 2017
• Est. completion date: August 27, 2018

Study information

• Verified date: July 2021
• Source: Vedic Lifesciences Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: August 27, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Vedic Lifesciences Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC pain score	Change in WOMAC pain score	84 days
Secondary	WOMAC stiffness score	Change in WOMAC stiffness score	84 days
Secondary	WOMAC physical function score	Change in WOMAC physical function score	84 days
Secondary	SF-36	Change in SF-36's various component scores.	84 days
Secondary	FACIT score	Change in FACIT score	84 days
Secondary	Rescue medication consumption	Change in rescue medication consumption.	84 days

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