Safety and Efficacy of Sahasthara ME vs Diclofenac ME for Treating Primary Knee Osteoarthritis

NCT06184685 | Completed Phase 2 DMC

• 1 other identifier: Ninnart Intharit 01
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Sahasthara is a traditional Thai herbal remedy used for the anti-inflammatory treatment of the musculoskeletal system, while diclofenac sodium is one of the most topically administered anti-inflammatory drug. However, there has not been scientifically researched regarding the efficacy and safety of SHT formulated as ME. Purpose: To assess the safety and effectiveness of Sahasthara microemulsion (SHT-ME) in comparison to a diclofenac microemulsion (DF-ME) in treating primary osteoarthritis (OA) of the knee. Methods: A randomized, double blinded clinical trial phase II was conducted. One treatment group received 1% SHT-ME, while the other received 2% DF-ME (2 ml, 3 times per day for 28 days) on their affected knee area. All patients were followed up at 14 and 28 days. Changes in the visual analogue scale (VAS) for pain as well as 100-meter walking times, the WOMAC index scores, and a global assessment were examined for efficacy. Clinical examinations, abnormalities in laboratory tests, and the incidence of adverse events (AEs) were assessed for safety.

Conditions

Primary Knee Osteoarthritis

Keywords

Clinical; Topical; Microemulsion; Sahasthara; Diclofenac; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• The WOMAC index

  It is a self-administered questionnaire from the latest version of WOMAC 3.1 (the Western Ontario and McMaster Universities Osteoarthritis Index) (Haq \& Davatchi, 2011; Roos et al., 1999). The patients were evaluated by the WOMAC index in terms of three domains: pain score ranged from 0 (no pain) to 4 (extreme pain); physical function score ranged from 0 (no difficulty) to 4 (the most severe difficulty); stiffness score ranged from 0 (no stiffness) to 4 (the worst stiffness).

  28 days (ฺDay0, Day14, Day28)

Secondary Outcomes (1)

• The visual analogue scale (VAS)

  28 days (ฺDay0, Day14, Day28)

Other Outcomes (2)

• 100-meter time walk

  28 days (ฺDay0, Day14, Day28)

• The global assessment

  28 days (ฺDay0, Day14, Day28)

Study Arms (2)

Sahasthara Microemulsion

EXPERIMENTAL

The extract of Sahasthara remedy was obtained by maceration with 95% ethanol for 3 days. The marc was re-extracted using the same process two more times. After that, the extract was filtered, concentrated using a rotary evaporator at 40 degree C and vacuum (Rotavapor R-205, Buchi, Switzerland), to gave a yield of 10.3% w/w. Finally, SHT ethanolic extract was formulated into a microemulsion with 1% (w/w) of extract and was stored in 50 ml bottles.

Drug: Sahasthara Microemulsion

Diclofenac Microemulsion

EXPERIMENTAL

DF-ME, which consists of 2% diclofenac sodium, was compounded according to the published instructions by RS Therapeutics Inc. (Canada) and stored in the same containers as SHT-ME.

Drug: Diclofenac Microemulsion

Interventions

Sahasthara Microemulsion DRUG

All patients were instructed to treat the knee with 2 ml, 3x/day, for 28 days. Each of the patients received the same appearance of drug packaging, which was not revealed until data analysis was completed, or medical emergency conditions would require an unblinding.

Also known as: Diclofenac Microemulsion

Sahasthara Microemulsion

Diclofenac Microemulsion DRUG

All patients were instructed to treat the knee with 2 ml, 3x/day, for 28 days. Each of the patients received the same appearance of drug packaging, which was not revealed until data analysis was completed, or medical emergency conditions would require an unblinding.

Diclofenac Microemulsion

Eligibility Criteria

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

You may qualify if:

• who had a pain score higher than 30 mm out of 100 mm on the visual analog scale (VAS)
• experiencing moderate to severe pain intensity from OA in one or both knees (patients who affected by knee OA bilaterally were evaluated, which more severely affected knee was included in the study) and had OA grade 1 to 3 (moderate/medium degree of pain) according to the Kellgren-Lawrence classification grading scale for OA severity

You may not qualify if:

• had a history of hypersensitivity to ingredients in SHT ME or DF-ME
• were pregnant or breast feeding
• were having any coexisting musculoskeletal diseases (including rheumatoid arthritis, septic arthritis, metabolic arthritis, gout, pseudogout, and traumatic arthritis ) or dermatologic disorder which affected the surrounding skin of the knees
• was assessed by body mass index (BMI) more than 32 kg/m2

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (1)

Thammasat University

Klong Luang, Changwat Pathum Thani, 12120, Thailand

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 28, 2023
• Study Start: October 20, 2021
• Primary Completion: November 17, 2021
• Study Completion: December 8, 2021
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)