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.

NCT07274371 | Active Not Recruiting

• 1 other identifier: BRAHMI-GOTUKOLA OIL- RCT-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disturbances in Perimenopause

Keywords

perimenopause; sleep disturbance

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

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.

Behavioral: Sesame oil Padabhyanga

Interventions

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.

Brahmi-Gotukola oil Padabhyanga( foot massage)

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.

Sesame oil padabhyanga ( foot massage)

Eligibility Criteria

• Age: 40 Years - 55 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saipriya Gowrishankar: lead
• Maharishi International University: collaborator

Study Sites (1)

Maharishi International University

Fairfield, Iowa, 52557, United States

Location

Related Publications (2)

• 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.

  PMID: 39631219 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.

  PMID: 28944165 BACKGROUND

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Saipriya Gowrishankar

  Maharishi International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: It is a single blinded trial so the participants does not know which noil they are using.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator and PhD Candidate in Physiology

Model Details: 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.

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 10, 2025
• Study Start: November 6, 2025
• Primary Completion: March 30, 2026
• Study Completion: April 30, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)