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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Sahastara remedy extract
* Drug: Diclofenac


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sahastara, Osteoarthritis, Herbal Medicine