Sahastara Remedy Extract Capsule in Primary Osteoarthritis of Clinical Trial Phase II

Efficacy and Safety of Sahastara Remedy Extract Capsules in Treating Primary Osteoarthritis of the Knee Compared With Diclofenac (Clinical Trial Phase II)

To study efficacy and safety of Sahastara 95% ethanolic extract capsules compared to treatment Primary osteoarthritis for primary osteoarthritis, it was compared with diclofenac (Phase II).

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: Diclofenac; Drug: Sahastara remedy extract

Detailed Description

Sample size 66 volunteers

The patients were divided randomly into 2 treatment groups. The patients in group 1 received the SHT extract 300 mg/day (1 capsule of 100 mg SHT extract three times daily before meals). The patients in group 2 received diclofenac sodium 75 mg/day (1 capsule of 25 mg diclofenac three times daily after meals). In addition, the patients in both groups received 20 mg of omeprazole, 1 capsule before breakfast for protects of Gastrointestinal adverse effects.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Thailand
  • BKK
    • Bangkok, BKK, Thailand, 11130
      • Recruiting
      • Mr. NARIN KAKATUM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• No pregnancy
• No Serious Medical Condition evaluated by Physical Examination and Laboratory results in 1 month before study
• No Supplementary food and/or Vitamin during the study Able to follow suggestion during the study

Exclusion Criteria:

• Uncontrolled Hypertension (BP>140/90 mm.Hg.) BMI > 30
• Have serious medical condition including Severe peptic ulcer, congestive heart disease, Liver and Renal dysfunction.
• On during use medicine including Rifampicin, Phenytoin, Propranolol, Theophylline

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 100 mg SHT extract; Drug: Sahastara remedy alcoholic extract comparison with diclofenac	Drug: Diclofenac; Diclofenac sodium, 25 mg enteric-coated tablets
Experimental: 25 mg dicolfenac; Drug: diclofenac comparison with diclofenac	Drug: Sahastara remedy extract; The concentration of SHT extract is 100 mg per capsule; Other Names: SHT extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score 1	Pain score from Visual analog scale	28 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score 2	Pain score from Modified WOMAC score (from Modified Thai WOMAC index)	28 day

Collaborators and Investigators

• Sponsor: Mr NARIN KAKATUM
• Investigators: Study Director: Associate Professor Arunporn Itharat, Ph.D., Faculty of Medicine, Thammasat University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): October 13, 2020
• Study Completion (Anticipated): October 13, 2020

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Osteoarthritis; Herbal Medicine; Sahastara
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: MTU-EC-TM-2-116_2/59

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