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

Mr NARIN KAKATUM

Status and phase: Unknown; Phase 2

Conditions: Osteoarthritis

Treatments: Drug: Diclofenac; Drug: Sahastara remedy extract

Study type: Interventional

Funder types: Other

Identifiers

NCT04591795

MTU-EC-TM-2-116_2/59

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

100 mg SHT extract

Experimental group

Description:

Drug: Sahastara remedy alcoholic extract comparison with diclofenac

Treatment:

Drug: Diclofenac

25 mg dicolfenac

Experimental group

Description:

Drug: diclofenac comparison with diclofenac

Treatment:

Drug: Sahastara remedy extract