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)

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04591795

Enrollment

Registered

2020-10-19

Start date

2018-01-01

Completion date

2020-10-13

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Sahastara, Osteoarthritis, Herbal Medicine

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.

Interventions

DRUGSahastara remedy extract

The concentration of SHT extract is 100 mg per capsule

DRUGDiclofenac

Diclofenac sodium, 25 mg enteric-coated tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Thailand

Contacts

Primary ContactMr.NARIN KAKATUM

narin.ka@ssru.ac.th0667867161

Backup ContactAssociate Professor Arunporn Itharat

iarunporn@yahoo.com0667867161

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026