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Stingless Bee Honey Augmentation in Major Depressive Disorders

NCT ID: NCT06723249

Last Updated: 2025-12-23

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

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2025-08-10

Brief Summary

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The goal of this clinical trial is to learn if stingless bee honey can be an augmentation supplement in Major Depressive Disorder (MDD) in adults. It will also learn about the adverse effects of the honey. The main questions it aims to answer are:

1. Is there any effect of SBH on depressive symptoms between intervention and control groups in MDD?
2. Are there any effects of SBH on BDNF between intervention and control groups in MDD?
3. Are there any effects of SBH on oxidative stress between intervention and control groups in MDD?
4. Are there any effects of SBH on verbal learning and memory between intervention and control groups in MDD?

There is no placebo.

Participants will:

Take stingless bee honey or nothing every day for 2 months Visit the clinic once every 4 weeks for checkups and tests Report adherence and adverse effects of stingless bee honey on a self-reported online questionnaires

Detailed Description

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Conditions

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Major Depressive Disorder (MDD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Intervention group

The participants under intervention group will receive stingless bee honey. At the same time, they will continue treatment as usual, their pharmacological like antidepressants or psychotherapy

Group Type ACTIVE_COMPARATOR

stingless bee honey

Intervention Type DIETARY_SUPPLEMENT

Participants under intervention group will receive 20g of stingless bee honey in a packet form but participants under control group will not receive any stingless bee honey

Control group

The participants in the control group will not receive stingless bee honey. They will continue treatment as usual, their pharmacological like antidepressants or psychotherapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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stingless bee honey

Participants under intervention group will receive 20g of stingless bee honey in a packet form but participants under control group will not receive any stingless bee honey

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Adults with ages 18 to 65
* with Major Depressive Disorder with scores of Beck Depression Inventory Malay version equal or more than 11

Exclusion Criteria

* Women in pregnancy or breast-feeding.
* Patients who with honey allergy or stingless bee honey allergy.
* Currently taking honey not limited to stingless bee honey or taken honey not limited to stingless bee honey in the past one month.
* comorbidity either with generalized anxiety disorder,
* panic disorder,
* social anxiety disorder,
* bipolar disorder,
* substance-use disorder,
* suicidal ideation or attempt,
* dementia,
* Alzheimer disease,
* diabetic,
* hypertension,
* chronic kidney disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universiti Sains Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Ong Wailoon

Student of Master of science in medical physiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sharifah Zubaidiah

Role: STUDY_DIRECTOR

Universiti Sains Malaysia

Mohd Zulkifli Mustafa

Role: STUDY_DIRECTOR

Universiti Sains Malaysia

Locations

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Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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USM/JEPeM/KK/24020180

Identifier Type: -

Identifier Source: org_study_id

TCTR20240621001

Identifier Type: REGISTRY

Identifier Source: secondary_id