Pilot Trial for Health Products in Psychological Distress and Insomnia

May 15, 2025 updated by: Prof. Zhang Zhang-Jin, The University of Hong Kong

A Pilot Randomized, Double-blinded, Placebo-controlled Trial on the Effects and Safety of Health Products Combining Traditional Chinese Medicines, Vitamins and Amino Acids in Psychological Distress and Insomnia

This is a pilot, single-site, two-armed, 16 weeks, double-blinded, randomized, placebo-controlled trial. A total of 60 patients aged 18-65 with psychological distress will be recruited. They will be randomly assigned to receive a combination of ES/VJ and ES/VC, or placebos (30 each) for 12 weeks. A 4-week observational phase will follow, and a post-intervention visit will be held at week 16. Written informed consent forms are obtained prior to commencement of the study from each participant. The primary outcome will be assessed using the Chinese version of the Beck Anxiety Inventory (BAI-C). The secondary outcomes include the Chinese version of the Beck Depression Inventory II (C-BDI-II) for depression, the Zung Self-Rating Anxiety Scale (SAS) as an additional assessment that measures intensity of anxiety, the Zung Self-Rating Depression Scale (SDS) as an additional assessment that measures intensity of depression, the Pittsburgh Sleep Quality Index (PSQI) for sleep quality, and the World Health Organization Quality of Life-Brief (WHOQOL-BREF) (HK version) for the general quality of life. Safety profile of ES/VJ and ES/VC will also be evaluated. A generalized linear mixed-effect model will be applied to compare outcomes over time in the 2 groups.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Psychological distress is a state of emotional suffering characterized by a combination of undifferentiated symptoms ranging from anxiety (e.g., restlessness), depression (e.g., loss of interest), stress, to functional impairment. Among these symptoms, anxiety and depression, which can be subclinical symptoms or clinical diagnoses, are highly comorbid. Somatic symptoms such as insomnia, lack of energy, and headache often accompany psychological distress, too.

Psychological distress can be a precursor and/ or feature of various mental disorders, where an individual's cognition, emotional regulation, or behavior is significantly disturbed. It is highly prevalent in the general population and has become more severe during and after the COVID-19 pandemic. The global prevalence of psychological distress with insomnia has dramatically risen since the COVID-19 pandemic, with 25.6% for anxiety, 23.1% for depression, and 17.4% for insomnia. In Hong Kong, 19% suffer from depression and 14% have anxiety. However, psychological distress and insomnia are often underdiagnosed and vastly undertreated because the condition of most individuals is mild, and some fear drugs would elicit undesirable side effects, which can sometimes be a greater risk than the disease itself. The development of novel alternative treatment strategies is therefore greatly desired.

The use of Chinese medicine and complementary medicine has gained increased attention in treating mental-related disorders in recent decades. A vast number of studies have suggested the benefits of Chinese medicines, vitamins, and amino acid supplementary products in improving anxiety, depression, and insomnia. It is possible that Chinese medicines, vitamins, and amino acids together can bring about beneficial synergistic effects in treating psychological distress and insomnia.

Extra Strength VitaJoy (ES/VJ) and Extra Strength Vita Calm (ES/VC) are two health products that are formulated by combining Chinese medicines, multiple vitamins and amino acids. Chinese medicines of ES/VJ and ES/VC are developed based on traditional Chinese medicine theory, aligning with compatibility of traditional Chinese Medicine and following the basic Chinese medicine formula structure of "Jun-Chen-Zuo-Shi". The two products are thought to tranquilize anxiety and nervousness, relieve sadness and depression, and improve sleeplessness. Our preliminary animal studies have suggested that Chinese medicines of ES/VJ noticeably reduced depression-like behavior in animal models, probably via the modulation of monoamine oxidase (MAO), without inducing herb-drug interaction or hypertension. Chinese medicines of ES/VC rapidly induced sleep in animals and reduced anxiety, and their efficacy was comparable to that of benzodiazepines. A pilot clinical observation revealed that Chinese medicine preparation of ES/VC could improve multiple sleep variables recorded by Actiwatch and diary. Although determination of synergistic effects between Chinese medicine, vitamins and amino acids is not addressed in this study due to time and resource limitations, results of our preliminary studies have encouraged us to further conduct a randomized controlled trial to confirm the effects and safety of the two products, in particular anxiety and depressive symptoms and insomnia alleviation.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zhang-Jin Zhang, MMed, PhD
  • Phone Number: +852 3917 6445
  • Email: zhangzj@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 000000
        • The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Subjects will be eligible for this study if they:

  1. are experiencing anxiety and/or depressive symptoms, as evidenced by a BAI-C score of at least 8 (no symptoms = 0-7; mild = 8-15; moderate = 16-25; severe = 26-63) and/or a C-BDI-II score of at least 14 (no symptoms = 0-13, mild = 14-19; moderate = 20-28; severe = 29-63), with symptoms persistent for more than 3 months; and
  2. are able to provide informed consent for participation, take medications and complete questionnaires as scheduled.

Exclusion Criteria:

Subjects will be excluded if they:

  1. have unstable systemic medical conditions that may limit their participation in the study (e.g., severe liver, cardiovascular or kidney impairment; gastrointestinal or endocrine dysfunction; malignancy; autoimmune disease or acute infectious disease);
  2. have bipolar disorder, psychotic disorder (e.g., schizophrenia), organic mental disorder (e.g., Alzheimer's disease), or significant cognitive impairment;
  3. present suicidal ideation (a score of ≥3 for all questionnaires of the Columbia-Suicide Severity Rating Scale (C-SSRS);
  4. have a history of brain injury or surgery;
  5. have alcohol abuse or substance abuse;
  6. are pregnant or in lactation, or are intend to conceive;
  7. have use of herbal remedies in the previous 6 months;
  8. have a history of hypersensitivity to investigational drug treatment or the active or inactive constituents of the tested products;
  9. have treatment with brain stimulation in the previous 6 months; or
  10. are involved in other interventional clinical studies in the last 3 months or any relevant condition potentially interfering with study evaluation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will be instructed to orally take placebo capsules each day, and will continue their current medications as usual, including prescribed sleep pills, anxiolytics, and antidepressants, for 12 weeks.
Dietary supplement: Placebo
Placebo Capsule, 4 capsules in the morning and evening respectively
Experimental: ES/VJ+ES/VC
Participants will be instructed to orally take ES/VJ and ES/VC capsules each day, and will continue their current medications as usual, including prescribed sleep pills, anxiolytics, and antidepressants, for 12 weeks.
Dietary supplement: Extra Strength VitaJoy (ES/VJ)
Extra Strength VitaJoy Capsule, 2 capsules in the morning
Dietary supplement: Extra Strength Vita Calm (ES/VC)
Extra Strength Vita Calm Capsule, 2 capsules in the evening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Beck Anxiety Inventory score
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16
Beck Anxiety Inventory (BAI-C) is used to measure the severity of anxiety and its overall score ranges from 0 to 63. A higher score indicates greater severity. Assessments will be conducted at baseline, week 4, week 8, week 12 and week 16 (post-intervention visit).
Baseline, Week 4, Week 8, Week 12, Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Beck Depression Inventory-II score
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16
Beck Depression Inventory-II (C-BDI-II) is used to measure the severity of depression and its overall score ranges from 0 to 63. A higher score indicates greater severity. Assessments will be conducted at baseline, week 4, week 8, week 12 and week 16 (post-intervention visit).
Baseline, Week 4, Week 8, Week 12, Week 16
Change in the Zung Self-Rating Anxiety Scale score
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16
Zung Self-Rating Anxiety Scale (SAS) is used to measure the severity of anxiety and its overall score ranges from 25 to 100. A higher score indicates greater severity. Assessments will be conducted at baseline, week 4, week 8, week 12 and week 16 (post-intervention visit).
Baseline, Week 4, Week 8, Week 12, Week 16
Change in the Zung Self-Rating Depression Scale score
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16
Zung Self-Rating Depression Scale (SDS) is used to measure the severity of depression and its overall score ranges from 25 to 100. A higher score indicates greater severity. Assessments will be conducted at baseline, week 4, week 8, week 12 and week 16 (post-intervention visit).
Baseline, Week 4, Week 8, Week 12, Week 16
Change in the Pittsburgh Sleep Quality Index score
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16
Pittsburgh Sleep Quality Index (PSQI) is used to assess sleep quality and its overall score ranges from 0 to 21. A higher score indicates more acute sleep disturbances. Assessments will be conducted at baseline, week 4, week 8, week 12 and week 16 (post-intervention visit).
Baseline, Week 4, Week 8, Week 12, Week 16
Change in the World Health Organization Quality of Life-Brief (HK version) score
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16
World Health Organization Quality of Life-Brief (WHOQOL-BREF) (HK version) is used to assess quality of life, with four quality of life domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items). Each individual item is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. A higher score indicates better quality of life. Assessments will be conducted at baseline, week 6 and week 12.
Baseline, Week 4, Week 8, Week 12, Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Zhang-Jin Zhang, MMed, PhD, School of Chinese Medicine, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

August 28, 2024

First Submitted That Met QC Criteria

August 28, 2024

First Posted (Actual)

August 30, 2024

Study Record Updates

Last Update Posted (Estimated)

May 20, 2025

Last Update Submitted That Met QC Criteria

May 15, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 24-183

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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