Study of Efficacy and Safety of Ginger Extract Compared W... | NCT02576808

Studies
Study of Efficacy and Safety of Ginger Extract Compared With Loratadine for Treatment of Allergic Rhinitis

NCT02576808

Sponsor

Thai Traditional Medical Knowledge Fund

Status

Completed

Last Update Posted

Oct 10, 2017Actual

Enrollment

80Actual

Phase

Phase 2

Conditions

Rhinitis,Allergic

Interventions

Ginger extract
Loratadine

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
TCTR20151001001	Registry Identifier	Thai Clinical Trials Registry (TCTR)

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Oct 2017Actual

Completion Date

Oct 2017Actual

First Submitted Date

Oct 12, 2015

First Submission Date that Met QC Criteria

Oct 13, 2015

First Posted Date

Oct 15, 2015Estimated

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 8, 2017

Last Update Posted Date

Oct 10, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rodsarin Yamprasert, Faculty of Medicine Thammasat University, Thai Traditional Medical Knowledge FundPrincipal Investigator

Lead Sponsor

Thai Traditional Medical Knowledge FundOTHER_GOV

Collaborators

Name	Class
Thammasat University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Efficacy and adverse effects of Ginger extract in treating allergic rhinitis patients compared with Loratadine.The double blind randomized controlled trial study was approved by the Human Research Ethics Committee of Thammasat University NO.1.

Detailed Description

The double blind randomized controlled trial study. Patients who meet the inclusion criteria and do not fall into any exclusion criteria will be randomly placed into the experimental group, who will receive ginger extract capsules, or the control group, who will receive loratadine for 42 days.

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

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ginger extract	Experimental	Drug	Drug: Ginger extract
Loratadine	Active Comparator	Drug	Drug: Loratadine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ginger extract	Drug	Ginger extract capsule at dose of 250 mg two times a day after meal daily for 42 days	Ginger extract

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nasal symptom	Nasal symptom from Total nasal symptom score	42days

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life	Quality of Life from Rhinoconjunctivitis Quality of Life Questionnaire	42days
Nasal patency	Nasal patency from Acoustic rhinometry

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients have moderate allergic rhinitis (itching and nasal obstruction, watery nasal discharge, sneezing and congestion )with a minimum total nasal symptom score 7 point
These patients do not have the respiratory disease such as tuberculosis, nasal polyps.
These patients do not have the history of disease: heart disease, kidney disease, liver disease, epilepsy, high blood pressure and severe asthma.
These patients are not pregnant or breastfeeding.
These patients have normal BMI and vital signs.

Exclusion Criteria:

Those who have taken anti-coagulant and anti-platelet aggregation medications.
Those who get serious side effects from Loratadine and ginger allergy.
Communication problems especially listening and interview.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rodsarin Yamprasert	Faculty of Medicine Thammasat University (Rangsit Campus)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thammasat University Hospital		Khlong Luang	Changwat Pathum Thani	12120	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32312261	Derived	Yamprasert R, Chanvimalueng W, Mukkasombut N, Itharat A. Ginger extract versus Loratadine in the treatment of allergic rhinitis: a randomized controlled trial. BMC Complement Med Ther. 2020 Apr 20;20(1):119. doi: 10.1186/s12906-020-2875-z.

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity

ID	Term
D003533	Cyproheptadine
D003986	Dibenzocycloheptenes
D001567	Benzocycloheptenes
D011084	Polycyclic Aromatic Hydrocarbons