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| Name | Class |
|---|---|
| Maharishi International University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brahmi-Gotukola oil padabhyanga | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline ( preintervention) and 14 days after starting the intervention |
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Inclusion Criteria:
Exclusion Criteria:
Eligibility for this study is limited to individuals who are biologically female and experiencing the perimenopausal transition showing irregularities in their monthly periods. Because the study investigates physiological changes that occur only in biological females during perimenopause, participants must have been assigned female at birth. Individuals who identify as women but were not assigned female at birth, as well as individuals who were assigned female at birth but do not experience menstrual physiology, are not eligible.
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| Name | Affiliation | Role |
|---|---|---|
| Saipriya Gowrishankar | Maharishi International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maharishi International University | Fairfield | Iowa | 52557 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39631219 | Background | 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. | |
| 28944165 | Background | Kravitz 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. |
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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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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.
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It is a single blinded trial so the participants does not know which noil they are using.
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| Sesame oil Padabhyanga | Behavioral | 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. |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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