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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04591795
• Other study ID #: MTU-EC-TM-2-116_2/59
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2018
• Est. completion date: October 13, 2020

Study information

• Verified date: October 2020
• Source: Thammasat University
• Contact: Mr.NARIN KAKATUM
• Phone: 0667867161
• Email: narin.ka[@]ssru.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 13, 2020
• Est. primary completion date: October 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Sahastara remedy extract
The concentration of SHT extract is 100 mg per capsule
• Diclofenac
Diclofenac sodium, 25 mg enteric-coated tablets

Locations

Country	Name	City	State
Thailand	Mr. NARIN KAKATUM	Bangkok	BKK

Sponsors (1)

Lead Sponsor	Collaborator
Mr NARIN KAKATUM

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score 1	Pain score from Visual analog scale	28 day
Secondary	Pain score 2	Pain score from Modified WOMAC score (from Modified Thai WOMAC index)	28 day