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.

NCT ID: NCT07274371

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-06
• Study Completion Date: 2026-04-30

Brief 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. 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.

Conditions

Sleep Disturbances in Perimenopause

Keywords

perimenopause; sleep disturbance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Brahmi-Gotukola oil Padabhyanga( foot massage)

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.

Group Type: EXPERIMENTAL

Brahmi-Gotukola oil padabhyanga

Intervention Type: 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.

Sesame oil padabhyanga ( foot massage)

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.

Group Type: ACTIVE_COMPARATOR

Sesame oil Padabhyanga

Intervention Type: 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.

Interventions

Brahmi-Gotukola oil padabhyanga

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.

Intervention Type: BEHAVIORAL

Sesame oil Padabhyanga

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Maharishi International University

OTHER

Sponsor Role: collaborator

Saipriya Gowrishankar

OTHER

Sponsor Role: lead

Responsible Party

Saipriya Gowrishankar

Principal Investigator and PhD Candidate in Physiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Saipriya Gowrishankar

Role: PRINCIPAL_INVESTIGATOR

Maharishi International University

Locations

Maharishi International University

Fairfield, Iowa, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 39631219 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28944165 (View on PubMed)

Other Identifiers

BRAHMI-GOTUKOLA OIL- RCT-01

Identifier Type: -

Identifier Source: org_study_id