Sahastara Remedy Extract Capsule in Primary Osteoarthriti... | NCT04591795

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

NCT04591795

Sponsor

Mr NARIN KAKATUM

Status

Unknown status

Last Update Posted

Oct 19, 2020Actual

Enrollment

80Estimated

Phase

Phase 2

Conditions

Osteoarthritis

Interventions

Sahastara remedy extract
Diclofenac

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Oct 13, 2020Actual

Completion Date

Oct 13, 2020Estimated

First Submitted Date

May 30, 2019

First Submission Date that Met QC Criteria

Oct 12, 2020

First Posted Date

Oct 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2020

Last Update Posted Date

Oct 19, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
100 mg SHT extract	Experimental	Drug: Sahastara remedy alcoholic extract comparison with diclofenac	Drug: Diclofenac
25 mg dicolfenac	Experimental	Drug: diclofenac comparison with diclofenac	Drug: Sahastara remedy extract

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sahastara remedy extract	Drug	The concentration of SHT extract is 100 mg per capsule	25 mg dicolfenac

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mr.NARIN KAKATUM	Contact	0667867161		narin.ka@ssru.ac.th
Associate Professor Arunporn Itharat	Contact	0667867161		iarunporn@yahoo.com

Overall Officials

Name	Affiliation	Role
Associate Professor Arunporn Itharat, Ph.D.	faculty of Medicine, Thammasat University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mr. NARIN KAKATUM	Recruiting	Bangkok	BKK	11130	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Oct 17, 2020
Reset	Nov 9, 2020

Submission Tracking

Estimated Results First Submitted Date

Oct 17, 2020

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 17, 2020			Nov 9, 2020

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004008	Diclofenac

Ancestor Terms

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided