Sleep Disturbances in PerimenopauseBG-SLEEPNCT07274371
A Study Comparing the Effects of Two Types of Natural Oils Used in a Bedtime Foot Massage Routine on Sleep and Emotional Well-Being in Perimenopausal Women.
A study testing Brahmi-Gotukola oil padabhyanga and Sesame oil Padabhyanga in people with Sleep Disturbances in Perimenopause, run by Saipriya Gowrishankar at 1 site in United States.
Trial summary
This study is being done to find out whether a nightly 5-minute foot massage (Padabhyanga) using Brahmi-Gotukola oil can help women ages 40 to 55 sleep better and feel calmer during perimenopause. Perimenopause is the time when periods start to change and many women begin to experience sleep problems and mood changes. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Sleep Disturbances in Perimenopause
- What is being tested?
- Brahmi-Gotukola oil padabhyanga and Sesame oil Padabhyanga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 40 to 55 years.
- Perimenopausal stage according to Stages of reproductive aging workshop +10 with menstrual irregularity PSQI scores above 5.
- Ability to understand and respond to study questions in English
- Willingness to participate in the study
Who cannot join
- Participants attained menopause.
- Current use of Hormone Replacement Therapy
- Current Psychiatric disorders like bipolar disorder and other severe mental illness that may interfere with partici[pation.
- Use of any anxiolytics, antidepressants
- History of Oopherectomy or hysterectomy .
- Conditions limiting foot massage include active foot injury, severe varicose vein, oprn wounds or any skin infection on the feet
- Any known allergy to sesame seeds
- Any other serious medical conditions according to investigators judgement that would ,make participation unsafe.
Trial locations and contacts
1 site in 1 country.
United States1 site
Maharishi International University
Fairfield, Iowa, 52557
About this study
Official title: Effects of Brahmi-Gotu Kola Oil Padabhyanga (Foot Massage) on Sleep and Mood Disturbances in Perimenopausal Women: a Pragmatic, Single-blind, Pilot Randomized Controlled Comparative Trial
This study is being done to find out whether a nightly 5-minute foot massage (Padabhyanga) using Brahmi-Gotukola oil can help women ages 40 to 55 sleep better and feel calmer during perimenopause. Perimenopause is the time when periods start to change and many women begin to experience sleep problems and mood changes. The study will also compare Brahmi-Gotukola oil to organic sesame oil, which will be used as the control oil.
Participants will do a simple guided 10-minute foot massage at home every night for 2 weeks using either Brahmi-Gotukola oil or organic sesame oil. They will fill out a short sleep log each morning to track their sleep. Before starting the study and again at the end of the 2-week period, they will complete questionnaires about their sleep and mood. Additional follow-up questionnaires will be completed in the 3rd and 4th weeks to see if any improvements continue even after the massage period is over.
Read more
This study aims to:
See whether Brahmi-Gotukola oil foot massage improves sleep in women experiencing perimenopausal sleep problems.
Find out whether Brahmi-Gotukola oil foot massage helps with mood and emotional well-being.
Compare Brahmi-Gotukola oil foot massage with sesame oil foot massage to determine whether Brahmi oil provides more benefits for sleep and mood.
Read the detailed description
Sleep disturbances and mood changes are commonly reported during the perimenopausal transition due to fluctuating ovarian hormones, alterations in circadian rhythm, and increased vulnerability to psychological stress. Many women prefer non-pharmacological interventions for sleep support, particularly those that can be performed at home, are low-risk, and do not interfere with daily responsibilities. Ayurveda describes Padabhyanga (foot massage) as a calming practice traditionally used to improve sleep , stabilize the nervous system, and support mental well-being. Brahmi (Bacopa monnieri) and Gotu Kola (Centella asiatica) are herbs used in classical Ayurvedic formulations and are known for their calming, sleep promoting actions. However, there is limited clinical research evaluating their effects on sleep and mood specifically in oil form especially in perimenopausal women.
This randomized controlled trial will evaluate whether a nightly 5-minute Padabhyanga using Brahmi-Gotu Kola oil can improve sleep quality and mood disturbances in women aged 40-55 experiencing perimenopausal changes. The trial will compare Brahmi-Gotukola oil to organic sesame oil, which is used as the control due to its neutral and widely accepted Ayurvedic use without the specific medhya (mind-supportive) actions attributed to Brahmi. The intervention will be self-administered at home for 14 consecutive nights.
Participants will complete baseline questionnaires assessing sleep quality and mood before the intervention begins. A short daily sleep log will be completed each morning during the 2-week intervention period to track changes in subjective sleep experience. Outcome assessment will be repeated immediately after the 2-week intervention, followed by two additional follow-up questionnaires in the 3rd and 4th weeks. The purpose of the follow-up assessments is to measure whether any observed improvements persist beyond the intervention period.
This study will generate preliminary evidence on the effectiveness of Ayurvedic Padabhyanga with Brahmi-Gotukola oil as a low-risk, self-care nighttime practice for perimenopausal women. Findings may support future larger-scale trials and may provide a practical, culturally relevant, and accessible approach to improving sleep quality and emotional well-being without pharmaceutical treatment.
- Conditions
- Sleep Disturbances in Perimenopause
- Being tested
- Brahmi-Gotukola oil padabhyanga, Sesame oil Padabhyanga
- Keywords
- perimenopause, sleep disturbance
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brahmi-Gotukola oil padabhyangaBehavioural
The intervention consists of applying Brahmi-Gotukola oil to both feet followed by a 10-minute Ayurvedic foot massage (Padabhyanga), performed once daily at bedtime for 14 consecutive days. Approximately 1 teaspoon (5 ml) of oil is applied to each foot. Massage is performed for 5 minutes per foot, focusing on the center of the foot, the base of the big toe and other toes, the web spaces, medial and lateral borders, the ankle joint, Achilles tendon, and the dorsum of the foot. After massage, excess oil may be gently wiped with a paper towel to reduce slipperiness, and participants may optionally wear cotton socks to prevent slipping. Massage is done about 20-30 minute before bed time , sitting in a quiet place. Intervention done after washing both feet. A parallel comparison group performs the same procedure using sesame oil instead of Brahmi-Gotu Kola oil.
Sesame oil PadabhyangaBehavioural
Participants apply sesame oil to both feet and perform the same 10-minute Ayurvedic foot massage (Padabhyanga) once daily at bedtime for 14 consecutive days. Approximately 1 teaspoon (5 ml) of oil is applied to each foot. The identical 5-minute per foot massage protocol is followed with emphasis on the center of the foot, toe bases, web spaces, medial/lateral borders, ankle joint, Achilles tendon, and dorsum. After massage, excess oil may be wiped with a paper towel, and cotton socks may be worn to prevent slipping.
| Study group | Role | What they receive |
|---|---|---|
| Brahmi-Gotukola oil Padabhyanga( foot massage) | Experimental | Participants apply Brahmi-Gotukola oil to both feet and perform a 10-minute Ayurvedic foot massage (Pada Abhyanga) once daily at bedtime for 14 consecutive days. Approximately 1 teaspoon (5 mi) of warm oil is applied to each foot. Massage is performed for 5 minutes per foot with focused strokes on the center of the foot, base of the big toe and other toes, web spaces, medial and lateral borders, ankle joint, Achilles tendon, and the dorsum. After massage, excess oil may be wiped with a paper towel to reduce slipperiness, and cotton socks may be worn. Receives: Behavioral: Brahmi-Gotukola oil padabhyanga |
| Sesame oil padabhyanga ( foot massage) | Active comparator | Participants apply sesame oil to both feet and perform the same 10 minute Ayurvedic foot massage (Padabhyanga) once daily at bedtime for 14 consecutive days. Approximately 1 teaspoon (5 ml) of oil is applied to each foot. The identical 5 minute per foot massage protocol is followed with emphasis on the center of the foot, toe bases, web spaces, medial/lateral borders, ankle joint, Achilles tendon, and dorsum. After massage, excess oil may be wiped with a paper towel, and cotton socks may be worn to prevent slipping. Receives: Behavioral: Sesame oil Padabhyanga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PSQI score from baseline to day 14
The Pittsburgh Sleep Quality Index (PSQI) will be administered at baseline (prior to intervention) and after 14 days of daily foot massage. This is a validated questionnaire that assesses sleep quality over the previous 1-month period, here adapted to a 2-week study duration. It includes 19 self-rated items generating a global score from 0 to 21, with higher scores indicating poorer sleep quality. A global score of 5 or more indicates clinically significant sleep disturbance. Change in total Pittsburg sleep quality index score will be calculated by subtracting Pretest score from Post test score.
Measured: Baseline to 14 days after intervention
Improvement in PSQI score from baseline to post test
The Pittsburgh Sleep Quality Index (PSQI) will be administered at baseline (prior to intervention) and after 14 days of daily foot massage. The PSQI is a validated questionnaire that assesses sleep quality over the previous 1-month period, here adapted to a 2-week study duration. It includes 19 self-rated items generating a global score from 0 to 21, with higher scores indicating poorer sleep quality. A global PSQI score >5 indicates clinically significant sleep disturbance. Change in total PSQI score will be calculated by subtracting post-intervention score from baseline score.
Measured: Baseline ( preintervention) and 14 days after starting the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start6 Nov 2025
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Disturbances in PerimenopauseStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This pragmatic randomized trial evaluates the effects of a nightly 10-minute self-administered Pada Abhyanga (foot massage) routine among perimenopausal women. All participants perform the same massage protocol, and are randomly assigned to use either Brahmi- Gotukola oil or plain sesame oil. The delivery, frequency, and duration of the intervention are identical in both groups; only the oil differs. Participants remain in their assigned group for the full study period, with no crossover.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saipriya Gowrishankar
- Sponsor type
- University, hospital or other
- Collaborators
- Maharishi International University
- Responsible party
- Sponsor-investigator, Saipriya Gowrishankar, Maharishi International University
- Investigators
- Saipriya Gowrishankar, Principal investigator, Maharishi International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274371
- Sponsor's protocol ID
- BRAHMI-GOTUKOLA OIL- RCT-01
- Acronym
- BG-SLEEP
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data will not be made publicly available. Data will be analyzed and reported only in aggregate form for scientific publications and presentations. No individual-level datasets will be shared outside of the research team due to institutional data privacy policies and participant consent limitations.
Publications
Sarhyal A, Chate S, Tubaki BR, Thakur R. Efficacy of Brahmi vati and Aswagandharista in major depressive disorder: A randomized controlled trial. J Ayurveda Integr Med. 2024 Nov-Dec;15(6):101022. doi: 10.1016/j.jaim.2024.101022. Epub 2024 Dec 3.
PubMed 39631219Kravitz HM, Janssen I, Bromberger JT, Matthews KA, Hall MH, Ruppert K, Joffe H. Sleep Trajectories Before and After the Final Menstrual Period in The Study of Women's Health Across the Nation (SWAN). Curr Sleep Med Rep. 2017 Sep;3(3):235-250. doi: 10.1007/s40675-017-0084-1. Epub 2017 Aug 5.
PubMed 28944165
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Brahmi-Gotu Kola Oil Padabhyanga (Foot Massage) on Sleep and Mood Disturbances in Perimenopausal Women: a Pragmatic, Single-blind, Pilot Randomized Controlled Comparative Trial
- ClinicalTrials.gov ID
- NCT07274371
- Acronym / sponsor ID
- BG-SLEEP / BRAHMI-GOTUKOLA OIL- RCT-01
- Conditions
- Sleep Disturbances in Perimenopause
- Keywords
- perimenopause, sleep disturbance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Saipriya GowrishankarUniversity, hospital or other
- Collaborators
- Maharishi International University
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 10 Dec 2025 (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.
This study is being done to find out whether a nightly 5-minute foot massage (Padabhyanga) using Brahmi-Gotukola oil can help women ages 40 to 55 sleep better and feel calmer during perimenopause. Perimenopause is the time when periods start to change and many women begin to experience sleep problems and mood changes. The study will also compare Brahmi-Gotukola oil to organic sesame oil, which will be used as the control oil.
Participants will do a simple guided 10-minute foot massage at home every night for 2 weeks using either Brahmi-Gotukola oil or organic sesame oil. They will fill out a short sleep log each morning to track their sleep. Before starting the study and again at the end of the 2-week period, they will complete questionnaires about their sleep and mood. Additional follow-up questionnaires will be completed in the 3rd and 4th weeks to see if any improvements continue even after the massage period is over.
This study aims to:
See whether Brahmi-Gotukola oil foot massage improves sleep in women experiencing perimenopausal sleep problems.
Find out whether Brahmi-Gotukola oil foot massage helps with mood and emotional well-being.
Compare Brahmi-Gotukola oil foot massage with sesame oil foot massage to determine whether Brahmi oil provides more benefits for sleep and mood.
Detailed description
Sleep disturbances and mood changes are commonly reported during the perimenopausal transition due to fluctuating ovarian hormones, alterations in circadian rhythm, and increased vulnerability to psychological stress. Many women prefer non-pharmacological interventions for sleep support, particularly those that can be performed at home, are low-risk, and do not interfere with daily responsibilities. Ayurveda describes Padabhyanga (foot massage) as a calming practice traditionally used to improve sleep , stabilize the nervous system, and support mental well-being. Brahmi (Bacopa monnieri) and Gotu Kola (Centella asiatica) are herbs used in classical Ayurvedic formulations and are known for their calming, sleep promoting actions. However, there is limited clinical research evaluating their effects on sleep and mood specifically in oil form especially in perimenopausal women.
This randomized controlled trial will evaluate whether a nightly 5-minute Padabhyanga using Brahmi-Gotu Kola oil can improve sleep quality and mood disturbances in women aged 40-55 experiencing perimenopausal changes. The trial will compare Brahmi-Gotukola oil to organic sesame oil, which is used as the control due to its neutral and widely accepted Ayurvedic use without the specific medhya (mind-supportive) actions attributed to Brahmi. The intervention will be self-administered at home for 14 consecutive nights.
Participants will complete baseline questionnaires assessing sleep quality and mood before the intervention begins. A short daily sleep log will be completed each morning during the 2-week intervention period to track changes in subjective sleep experience. Outcome assessment will be repeated immediately after the 2-week intervention, followed by two additional follow-up questionnaires in the 3rd and 4th weeks. The purpose of the follow-up assessments is to measure whether any observed improvements persist beyond the intervention period.
This study will generate preliminary evidence on the effectiveness of Ayurvedic Padabhyanga with Brahmi-Gotukola oil as a low-risk, self-care nighttime practice for perimenopausal women. Findings may support future larger-scale trials and may provide a practical, culturally relevant, and accessible approach to improving sleep quality and emotional well-being without pharmaceutical treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This pragmatic randomized trial evaluates the effects of a nightly 10-minute self-administered Pada Abhyanga (foot massage) routine among perimenopausal women. All participants perform the same massage protocol, and are randomly assigned to use either Brahmi- Gotukola oil or plain sesame oil. The delivery, frequency, and duration of the intervention are identical in both groups; only the oil differs. Participants remain in their assigned group for the full study period, with no crossover.
| Arm | Type | Receives |
|---|---|---|
| Brahmi-Gotukola oil Padabhyanga( foot massage) | Experimental | Behavioral: Brahmi-Gotukola oil padabhyangaParticipants apply Brahmi-Gotukola oil to both feet and perform a 10-minute Ayurvedic foot massage (Pada Abhyanga) once daily at bedtime for 14 consecutive days. Approximately 1 teaspoon (5 mi) of warm oil is applied to each foot. Massage is performed for 5 minutes per foot with focused strokes on the center of the foot, base of the big toe and other toes, web spaces, medial and lateral borders, ankle joint, Achilles tendon, and the dorsum. After massage, excess oil may be wiped with a paper towel to reduce slipperiness, and cotton socks may be worn. |
| Sesame oil padabhyanga ( foot massage) | Active comparator | Behavioral: Sesame oil PadabhyangaParticipants apply sesame oil to both feet and perform the same 10 minute Ayurvedic foot massage (Padabhyanga) once daily at bedtime for 14 consecutive days. Approximately 1 teaspoon (5 ml) of oil is applied to each foot. The identical 5 minute per foot massage protocol is followed with emphasis on the center of the foot, toe bases, web spaces, medial/lateral borders, ankle joint, Achilles tendon, and dorsum. After massage, excess oil may be wiped with a paper towel, and cotton socks may be worn to prevent slipping. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 40 to 55 years.
- Perimenopausal stage according to Stages of reproductive aging workshop +10 with menstrual irregularity PSQI scores above 5.
- Ability to understand and respond to study questions in English
- Willingness to participate in the study
Key exclusion criteria (8 listed)
- Participants attained menopause.
- Current use of Hormone Replacement Therapy
- Current Psychiatric disorders like bipolar disorder and other severe mental illness that may interfere with partici[pation.
- Use of any anxiolytics, antidepressants
- History of Oopherectomy or hysterectomy .
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 |
|---|---|---|
| Brahmi-Gotukola oil padabhyangaThe intervention consists of applying Brahmi-Gotukola oil to both feet followed by a 10-minute Ayurvedic foot massage (Padabhyanga), performed once daily at bedtime for 14 consecutive days. Approximately 1 teaspoon (5 ml) of oil is applied to each foot. Massage is performed for 5 minutes per foot, focusing on the center of the foot, the base of the big toe and other toes, the web spaces, medial and lateral borders, the ankle joint, Achilles tendon, and the dorsum of the foot. After massage, excess oil may be gently wiped with a paper towel to reduce slipperiness, and participants may optionally wear cotton socks to prevent slipping. Massage is done about 20-30 minute before bed time , sitting in a quiet place. Intervention done after washing both feet. A parallel comparison group performs the same procedure using sesame oil instead of Brahmi-Gotu Kola oil. | Behavioural | Brahmi-Gotukola oil Padabhyanga( foot massage) |
| Sesame oil PadabhyangaParticipants apply sesame oil to both feet and perform the same 10-minute Ayurvedic foot massage (Padabhyanga) once daily at bedtime for 14 consecutive days. Approximately 1 teaspoon (5 ml) of oil is applied to each foot. The identical 5-minute per foot massage protocol is followed with emphasis on the center of the foot, toe bases, web spaces, medial/lateral borders, ankle joint, Achilles tendon, and dorsum. After massage, excess oil may be wiped with a paper towel, and cotton socks may be worn to prevent slipping. | Behavioural | Sesame oil padabhyanga ( foot massage) |
Primary outcome
Change in PSQI score from baseline to day 14
Time frame: Baseline to 14 days after intervention
The Pittsburgh Sleep Quality Index (PSQI) will be administered at baseline (prior to intervention) and after 14 days of daily foot massage. This is a validated questionnaire that assesses sleep quality over the previous 1-month period, here adapted to a 2-week study duration. It includes 19 self-rated items generating a global score from 0 to 21, with higher scores indicating poorer sleep quality. A global score of 5 or more indicates clinically significant sleep disturbance. Change in total Pittsburg sleep quality index score will be calculated by subtracting Pretest score from Post test score.
Improvement in PSQI score from baseline to post test
Time frame: Baseline ( preintervention) and 14 days after starting the intervention
The Pittsburgh Sleep Quality Index (PSQI) will be administered at baseline (prior to intervention) and after 14 days of daily foot massage. The PSQI is a validated questionnaire that assesses sleep quality over the previous 1-month period, here adapted to a 2-week study duration. It includes 19 self-rated items generating a global score from 0 to 21, with higher scores indicating poorer sleep quality. A global PSQI score >5 indicates clinically significant sleep disturbance. Change in total PSQI score will be calculated by subtracting post-intervention score from baseline score.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Background: PubMed 39631219Sarhyal A, Chate S, Tubaki BR, Thakur R. Efficacy of Brahmi vati and Aswagandharista in major depressive disorder: A randomized controlled trial. J Ayurveda Integr Med. 2024 Nov-Dec;15(6):101022. doi: 10.1016/j.jaim.2024.101022. Epub 2024 Dec 3.
- Background: PubMed 28944165Kravitz HM, Janssen I, Bromberger JT, Matthews KA, Hall MH, Ruppert K, Joffe H. Sleep Trajectories Before and After the Final Menstrual Period in The Study of Women's Health Across the Nation (SWAN). Curr Sleep Med Rep. 2017 Sep;3(3):235-250. doi: 10.1007/s40675-017-0084-1. Epub 2017 Aug 5.
- Individual participant dataSharing planned: No. De-identified individual participant data will not be made publicly available. Data will be analyzed and reported only in aggregate form for scientific publications and presentations. No individual-level datasets will be shared outside of the research team due to institutional data privacy policies and participant consent limitations.
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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.
Saipriya Gowrishankar principal investigator
Maharishi International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brahmi-Gotukola oil padabhyanga and Sesame oil Padabhyanga in people with Sleep Disturbances in Perimenopause, run by Saipriya Gowrishankar at 1 site in United States.
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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2025. 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 United States. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PSQI score from baseline to day 14 (time frame: Baseline to 14 days after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07274371, which also lists 2 linked publications.
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 18 Dec 2025.