InsomniaNCT06171308
Effect of Moxibustion Intervention on Insomnia Patients
A study testing Traditional Chinese moxibustion apparatus in people with Insomnia and Moxibustion, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Type of study:clinical trial Purpose of research:To explore the efficacy and safety of moxibustion combined with Traditional Chinese and Western medicine in treating insomnia. Describe participant population/health conditions:120 insomnia patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia, Moxibustion
- What is being tested?
- Traditional Chinese moxibustion apparatus
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria of ICD-10 insomnia;
- In line with the relevant diagnostic criteria of TCM syndrome differentiation of heart-spleen and deficiency type insomnia (TCM syndrome diagnosis criteria according to the 1993 Ministry of Health "Guidelines for Clinical Research on the treatment of Insomnia with new Chinese Medicine" standards: heart-spleen and deficiency: palpitation, amnesia, dizziness, poor and tired, pale face, easy to sweat, tongue, thin coat, thin pulse);
- Pittsburgh Sleep Quality Index (PSQI) score > 7 at baseline;
- The treatment plan used in this study is tolerable, cooperative and compliant;
- Regardless of gender, age 18-65 years old;
- Understand the procedure and content of the test, and voluntarily sign the informed consent;
Who cannot join
- Participating in other clinical studies;
- Exclude patients with serious physical diseases or diseases that may affect the evaluation of the test;
- there is a clear risk of suicide or danger to oneself or others;
- Exclude pregnant or lactating women, or those planning pregnancy;
- Persons with alcohol and drug dependence within 1 year prior to screening.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
moxibustion equipment（Zhongshan Jiaxun medical equipment Co., LTD）
Shanghai, Shanghai Municipality
Yi Mei, Undergraduate, 18017311269, 18017311269@qq.com
About this study
Type of study:clinical trial Purpose of research:To explore the efficacy and safety of moxibustion combined with Traditional Chinese and Western medicine in treating insomnia.
Describe participant population/health conditions:120 insomnia patients
Read the detailed description
Type of study:clinical trial Purpose of research:To explore the efficacy and safety of moxibustion combined with Traditional Chinese and Western medicine in treating insomnia.
Describe participant population/health conditions:120 insomnia patients The participants were enrolled according to the principle of randomization and single blindness, and the analysis was adjusted every quarter according to the research schedule. The study group was treated with traditional Chinese moxibustion and western medicine. The control group was treated with only western medicine.
Clinical evaluation of the main efficacy indicators: The score of PSQI scale was assessed. The reduction rate of PSQI scale was ≥ 25% as effective, and the difference between the two groups was compared as the basis for evaluating the main efficacy indicators. The efficacy of insomnia symptoms was evaluated by the difference of PSQI score reduction rate between groups before and after intervention.
Secondary clinical outcome measures: Quality of Life Scale (SQLS), SF-36 scale, Clinical Gross Impression Scale (CGI), adverse reaction（TESS） .
- Conditions
- Insomnia, Moxibustion
- Being tested
- Traditional Chinese moxibustion apparatus
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese moxibustion apparatusDevice
The study group was treated with traditional Chinese moxibustion and western medicine. The control group was treated with blank moxibustion and western medicine.
- The study group: Using the moxibustion, select specific 3 groups of acupoints. Select a group of acupuncture points every day, in the moxibustion treatment for 20 minutes, 4 weeks for a course of treatment.
- The control group: Using the moxibustion with blank patch, select specific 3 groups of acupoints. Select a group of acupuncture points every day, in the moxibustion treatment for 20 minutes, 4 weeks for a course of treatment.
- The treatment period is 4 weeks, which is a course of treatment, and the observation period is 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| The study group(using the moxibustion) | Active comparator | The study group was treated with traditional Chinese moxibustion and western medicine. The control group was treated with blank moxibustion and western medicine.
1. The study group: Using the moxibustion, select specific 3 groups of acupoints. Select a group of acupuncture points every day, in the moxibustion treatment for 20 minutes, 4 weeks for a course of treatment.
2. The control group: Using the moxibustion with blank patch, select specific 3 groups of acupoints. Select a group of acupuncture points every day, in the moxibustion treatment for 20 minutes, 4 weeks for a course of treatment.
3. The treatment period is 4 weeks, which is a course of treatment, and the observation period is 8 weeks. Receives: Device: Traditional Chinese moxibustion apparatus |
| The control group(using the moxibustion with blank patch) | Placebo comparator | The study group was treated with traditional Chinese moxibustion and western medicine. The control group was treated with blank moxibustion and western medicine.
1. The study group: Using the moxibustion, select specific 3 groups of acupoints. Select a group of acupuncture points every day, in the moxibustion treatment for 20 minutes, 4 weeks for a course of treatment.
2. The control group: Using the moxibustion with blank patch, select specific 3 groups of acupoints. Select a group of acupuncture points every day, in the moxibustion treatment for 20 minutes, 4 weeks for a course of treatment.
3. The treatment period is 4 weeks, which is a course of treatment, and the observation period is 8 weeks. Receives: Device: Traditional Chinese moxibustion apparatus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The score of PSQI
The reduction rate of PSQI scale ≥25% was regarded as effective, and the difference between the two groups was compared as the basis for evaluating the main therapeutic effect indicators. The efficacy of insomnia symptoms was evaluated by the difference in the reduction rate of PSQI scores between the two groups before and after the intervention.
Measured: Baseline, week two, week four, week eight
Secondary outcomes (4)
The score of Quality of Life Scale (SQLS)
The score reduction rate was taken as the therapeutic grade standard, and the score reduction rate =[(pre-treatment score - post-treatment score) ÷ pre-treatment score]×100%. The score reduction rate after treatment was ≥ 75% for clinical recovery, 50%-75% for obvious effect, 25%-50% for effective, and < 25% for ineffective. Total response rate = (effective + effective + cured)/total cases *100%.
Measured: Baseline, week two, week four, week eight
The score of SF-36 scale
The score reduction rate was taken as the therapeutic grade standard, and the score reduction rate =[(pre-treatment score - post-treatment score) ÷ pre-treatment score]×100%. The score reduction rate after treatment was ≥ 75% for clinical recovery, 50%-75% for obvious effect, 25%-50% for effective, and < 25% for ineffective. Total response rate = (effective + effective + cured)/total cases *100%.
Measured: Baseline, week two, week four, week eight
The score of Clinical Gross Impression Scale (CGI)
The score reduction rate was taken as the therapeutic grade standard, and the score reduction rate =[(pre-treatment score - post-treatment score) ÷ pre-treatment score]×100%. The score reduction rate after treatment was ≥ 75% for clinical recovery, 50%-75% for obvious effect, 25%-50% for effective, and < 25% for ineffective. Total response rate = (effective + effective + cured)/total cases *100%.
Measured: Baseline, week two, week four, week eight
adverse reaction（TESS）evaluation
The score reduction rate was taken as the therapeutic grade standard, and the score reduction rate =[(pre-treatment score - post-treatment score) ÷ pre-treatment score]×100%. The score reduction rate after treatment was ≥ 75% for clinical recovery, 50%-75% for obvious effect, 25%-50% for effective, and < 25% for ineffective. Total response rate = (effective + effective + cured)/total cases *100%.
Measured: Baseline, week two, week four, week eight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171308
- Sponsor's protocol ID
- 2022-YJ14
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Moxibustion Intervention on Insomnia Patients
- ClinicalTrials.gov ID
- NCT06171308
- Acronym / sponsor ID
- 2022-YJ14
- Conditions
- Insomnia, Moxibustion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type of study:clinical trial Purpose of research:To explore the efficacy and safety of moxibustion combined with Traditional Chinese and Western medicine in treating insomnia.
Describe participant population/health conditions:120 insomnia patients
Detailed description
Type of study:clinical trial Purpose of research:To explore the efficacy and safety of moxibustion combined with Traditional Chinese and Western medicine in treating insomnia.
Describe participant population/health conditions:120 insomnia patients The participants were enrolled according to the principle of randomization and single blindness, and the analysis was adjusted every quarter according to the research schedule. The study group was treated with traditional Chinese moxibustion and western medicine. The control group was treated with only western medicine.
Clinical evaluation of the main efficacy indicators: The score of PSQI scale was assessed. The reduction rate of PSQI scale was ≥ 25% as effective, and the difference between the two groups was compared as the basis for evaluating the main efficacy indicators. The efficacy of insomnia symptoms was evaluated by the difference of PSQI score reduction rate between groups before and after intervention.
Secondary clinical outcome measures: Quality of Life Scale (SQLS), SF-36 scale, Clinical Gross Impression Scale (CGI), adverse reaction（TESS） .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The study group(using the moxibustion) | Active comparator | Device: Traditional Chinese moxibustion apparatusThe study group was treated with traditional Chinese moxibustion and western medicine. The control group was treated with blank moxibustion and western medicine. 1. The study group: Using the moxibustion, select specific 3 groups of acupoints. Select a group of acupuncture points every day, in the moxibustion treatment for 20 minutes, 4 weeks for a course of treatment. 2. The control group: Using the moxibustion with blank patch, select specific 3 groups of acupoints. Select a group of acupuncture points every day, in the moxibustion treatment for 20 minutes, 4 weeks for a course of treatment. 3. The treatment period is 4 weeks, which is a course of treatment, and the observation period is 8 weeks. |
| The control group(using the moxibustion with blank patch) | Placebo comparator | Device: Traditional Chinese moxibustion apparatusThe study group was treated with traditional Chinese moxibustion and western medicine. The control group was treated with blank moxibustion and western medicine. 1. The study group: Using the moxibustion, select specific 3 groups of acupoints. Select a group of acupuncture points every day, in the moxibustion treatment for 20 minutes, 4 weeks for a course of treatment. 2. The control group: Using the moxibustion with blank patch, select specific 3 groups of acupoints. Select a group of acupuncture points every day, in the moxibustion treatment for 20 minutes, 4 weeks for a course of treatment. 3. The treatment period is 4 weeks, which is a course of treatment, and the observation period is 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meet the diagnostic criteria of ICD-10 insomnia;
- In line with the relevant diagnostic criteria of TCM syndrome differentiation of heart-spleen and deficiency type insomnia (TCM syndrome diagnosis criteria according to the 1993 Ministry of Health "Guidelines for Clinical Research on the treatment of Insomnia with new Chinese Medicine" standards: heart-spleen and deficiency: palpitation, amnesia, dizziness, poor and tired, pale face, easy to sweat, tongue, thin coat, thin pulse);
- Pittsburgh Sleep Quality Index (PSQI) score > 7 at baseline;
- The treatment plan used in this study is tolerable, cooperative and compliant;
- Regardless of gender, age 18-65 years old;
Key exclusion criteria (5 listed)
- Participating in other clinical studies;
- Exclude patients with serious physical diseases or diseases that may affect the evaluation of the test;
- there is a clear risk of suicide or danger to oneself or others;
- Exclude pregnant or lactating women, or those planning pregnancy;
- Persons with alcohol and drug dependence within 1 year prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Chinese moxibustion apparatusThe study group was treated with traditional Chinese moxibustion and western medicine. The control group was treated with blank moxibustion and western medicine. 1. The study group: Using the moxibustion, select specific 3 groups of acupoints. Select a group of acupuncture points every day, in the moxibustion treatment for 20 minutes, 4 weeks for a course of treatment. 2. The control group: Using the moxibustion with blank patch, select specific 3 groups of acupoints. Select a group of acupuncture points every day, in the moxibustion treatment for 20 minutes, 4 weeks for a course of treatment. 3. The treatment period is 4 weeks, which is a course of treatment, and the observation period is 8 weeks. | Device | The control group(using the moxibustion with blank patch), The study group(using the moxibustion) |
Primary outcome
The score of PSQI
Time frame: Baseline, week two, week four, week eight
The reduction rate of PSQI scale ≥25% was regarded as effective, and the difference between the two groups was compared as the basis for evaluating the main therapeutic effect indicators. The efficacy of insomnia symptoms was evaluated by the difference in the reduction rate of PSQI scores between the two groups before and after the intervention.
4 secondary outcomes
The score of Quality of Life Scale (SQLS)
Time frame: Baseline, week two, week four, week eight
The score of SF-36 scale
Time frame: Baseline, week two, week four, week eight
The score of Clinical Gross Impression Scale (CGI)
Time frame: Baseline, week two, week four, week eight
adverse reaction（TESS）evaluation
Time frame: Baseline, week two, week four, week eight
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Chinese moxibustion apparatus in people with Insomnia and Moxibustion, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JING Cai, Undergraduate (13524000307, 1994510cj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The score of PSQI (time frame: Baseline, week two, week four, week eight). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.