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

NCT ID: NCT04591795

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-10-13

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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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100 mg SHT extract

Drug: Sahastara remedy alcoholic extract comparison with diclofenac

Group Type EXPERIMENTAL

Diclofenac

Intervention Type DRUG

Diclofenac sodium, 25 mg enteric-coated tablets

25 mg dicolfenac

Drug: diclofenac comparison with diclofenac

Group Type EXPERIMENTAL

Sahastara remedy extract

Intervention Type DRUG

The concentration of SHT extract is 100 mg per capsule

Interventions

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Sahastara remedy extract

The concentration of SHT extract is 100 mg per capsule

Intervention Type DRUG

Diclofenac

Diclofenac sodium, 25 mg enteric-coated tablets

Intervention Type DRUG

Other Intervention Names

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SHT extract

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mr NARIN KAKATUM

OTHER

Sponsor Role lead

Responsible Party

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Mr NARIN KAKATUM

Faculty of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Associate Professor Arunporn Itharat, Ph.D.

Role: STUDY_DIRECTOR

faculty of Medicine, Thammasat University

Locations

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Mr. NARIN KAKATUM

Bangkok, BKK, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Mr.NARIN KAKATUM

Role: CONTACT

0667867161

Associate Professor Arunporn Itharat

Role: CONTACT

0667867161

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id

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