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

NCT ID: NCT02576808

Last Updated: 2017-10-10

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-10-31

Brief Summary

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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

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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.

Conditions

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Rhinitis,Allergic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ginger extract

Drug

Group Type EXPERIMENTAL

Ginger extract

Intervention Type DRUG

Ginger extract capsule at dose of 250 mg two times a day after meal daily for 42 days

Loratadine

Drug

Group Type ACTIVE_COMPARATOR

Loratadine

Intervention Type DRUG

Loratadine tablet at dose of 10 mg one times a day after morning meal daily for 42 days

Interventions

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Ginger extract

Ginger extract capsule at dose of 250 mg two times a day after meal daily for 42 days

Intervention Type DRUG

Loratadine

Loratadine tablet at dose of 10 mg one times a day after morning meal daily for 42 days

Intervention Type DRUG

Other Intervention Names

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Clarityne

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thammasat University

OTHER

Sponsor Role collaborator

Thai Traditional Medical Knowledge Fund

OTHER_GOV

Sponsor Role lead

Responsible Party

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Rodsarin Yamprasert

Faculty of Medicine Thammasat University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rodsarin Yamprasert

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Thammasat University (Rangsit Campus)

Locations

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Thammasat University Hospital

Khlong Luang, Changwat Pathum Thani, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type DERIVED
PMID: 32312261 (View on PubMed)

Other Identifiers

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TCTR20151001001

Identifier Type: REGISTRY

Identifier Source: secondary_id

MTU-EC-TM-4-077/57

Identifier Type: -

Identifier Source: org_study_id