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

Phase 2

• Conditions: Osteoarthritis
• Interventions: Drug: Sahastara remedy extract; Drug: Diclofenac

• Registration Number: NCT04591795
• Lead Sponsor: Mr NARIN KAKATUM

Brief Summary

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).

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 Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2019-05-30
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-12
• Last Update Submitted: 2020-10-12
• Primary Completion: 2020-10-13
• Study Completion: 2020-10-13
• Study First Posted: 2020-10-19
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
25 mg dicolfenac	Sahastara remedy extract	Drug: diclofenac comparison with diclofenac
100 mg SHT extract	Diclofenac	Drug: Sahastara remedy alcoholic extract comparison with diclofenac

Primary Outcome Measures

Name	Time	Method
Pain score 1	28 day	Pain score from Visual analog scale

Secondary Outcome Measures

Name	Time	Method
Pain score 2	28 day	Pain score from Modified WOMAC score (from Modified Thai WOMAC index)

Trial Locations

Locations (1)

Mr. NARIN KAKATUM; 🇹🇭 Bangkok, BKK, Thailand