Pilot Trial for Health Products in Psychological Distress and Insomnia

NCT ID: NCT06579183

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2028-12-31

Brief Summary

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.

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.

Conditions

Psychological Distress; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Extra Strength VitaJoy (ES/VJ)

Intervention Type: DIETARY_SUPPLEMENT

Extra Strength VitaJoy Capsule, 2 capsules in the morning

Extra Strength Vita Calm (ES/VC)

Intervention Type: DIETARY_SUPPLEMENT

Extra Strength Vita Calm Capsule, 2 capsules in the evening

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo Capsule, 4 capsules in the morning and evening respectively

Interventions

Extra Strength VitaJoy (ES/VJ)

Extra Strength VitaJoy Capsule, 2 capsules in the morning

Intervention Type: DIETARY_SUPPLEMENT

Extra Strength Vita Calm (ES/VC)

Extra Strength Vita Calm Capsule, 2 capsules in the evening

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo Capsule, 4 capsules in the morning and evening respectively

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Prof. Zhang Zhang-Jin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhang-Jin Zhang, MMed, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Chinese Medicine, The University of Hong Kong

Locations

The University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Central Contacts

Zhang-Jin Zhang, MMed, PhD

Role: CONTACT

zhangzj@hku.hk

+852 3917 6445

References

Morin CM, Bjorvatn B, Chung F, Holzinger B, Partinen M, Penzel T, Ivers H, Wing YK, Chan NY, Merikanto I, Mota-Rolim S, Macedo T, De Gennaro L, Leger D, Dauvilliers Y, Plazzi G, Nadorff MR, Bolstad CJ, Sieminski M, Benedict C, Cedernaes J, Inoue Y, Han F, Espie CA. Insomnia, anxiety, and depression during the COVID-19 pandemic: an international collaborative study. Sleep Med. 2021 Nov;87:38-45. doi: 10.1016/j.sleep.2021.07.035. Epub 2021 Aug 4.

Reference Type: BACKGROUND

PMID: 34508986 (View on PubMed)

Choi EPH, Hui BPH, Wan EYF. Depression and Anxiety in Hong Kong during COVID-19. Int J Environ Res Public Health. 2020 May 25;17(10):3740. doi: 10.3390/ijerph17103740.

Reference Type: BACKGROUND

PMID: 32466251 (View on PubMed)

Sarris J, Ravindran A, Yatham LN, Marx W, Rucklidge JJ, McIntyre RS, Akhondzadeh S, Benedetti F, Caneo C, Cramer H, Cribb L, de Manincor M, Dean O, Deslandes AC, Freeman MP, Gangadhar B, Harvey BH, Kasper S, Lake J, Lopresti A, Lu L, Metri NJ, Mischoulon D, Ng CH, Nishi D, Rahimi R, Seedat S, Sinclair J, Su KP, Zhang ZJ, Berk M. Clinician guidelines for the treatment of psychiatric disorders with nutraceuticals and phytoceuticals: The World Federation of Societies of Biological Psychiatry (WFSBP) and Canadian Network for Mood and Anxiety Treatments (CANMAT) Taskforce. World J Biol Psychiatry. 2022 Jul;23(6):424-455. doi: 10.1080/15622975.2021.2013041. Epub 2022 Mar 21.

Reference Type: BACKGROUND

PMID: 35311615 (View on PubMed)

Sarris J, Marx W, Ashton MM, Ng CH, Galvao-Coelho N, Ayati Z, Zhang ZJ, Kasper S, Ravindran A, Harvey BH, Lopresti A, Mischoulon D, Amsterdam J, Yatham LN, Berk M. Plant-based Medicines (Phytoceuticals) in the Treatment of Psychiatric Disorders: A Meta-review of Meta-analyses of Randomized Controlled Trials: Les medicaments a base de plantes (phytoceutiques) dans le traitement des troubles psychiatriques: une meta-revue des meta-analyses d'essais randomises controles. Can J Psychiatry. 2021 Oct;66(10):849-862. doi: 10.1177/0706743720979917. Epub 2021 Feb 18.

Reference Type: BACKGROUND

PMID: 33596697 (View on PubMed)

Other Identifiers

UW 24-183

Identifier Type: -

Identifier Source: org_study_id