Brahmi-Gotukola Oil Foot Massage for Insomnia

(BG-SLEEP Trial)

Overseen By Sangeetha Sharma, BAMS,MD (Ayu), PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Saipriya Gowrishankar

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this 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.

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.

Who Is on the Research Team?

Saipriya Gowrishankar

Principal Investigator

Maharishi International University

Are You a Good Fit for This Trial?

This trial is for women aged 40 to 55 going through perimenopause, which is when periods become irregular and sleep issues or mood changes may start. Participants will use a nightly foot massage technique at home to help with sleep and mood.

Inclusion Criteria

I am a woman aged 40-55, in perimenopause with irregular periods and poor sleep quality.

Ability to understand and respond to study questions in English

I am willing to participate in the study.

Exclusion Criteria

I am currently using hormone replacement therapy.

History of psychiatric disorders like bipolar disorder

I cannot have foot massages due to injury or varicose veins.

What Are the Treatments Tested in This Trial?

Interventions

• Brahmi-Gotukola oil padabhyanga
• Sesame oil Padabhyanga

Trial Overview The study tests if a 5-minute nightly foot massage using Brahmi-Gotukola oil can improve sleep and calmness in perimenopausal women compared to using organic sesame oil. Women will track their sleep daily and complete questionnaires about their well-being.

How Is the Trial Designed?

Group I: Brahmi-Gotukola oil Padabhyanga( foot massage) Experimental Treatment 1 Intervention

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 II: Sesame oil padabhyanga ( foot massage) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Saipriya Gowrishankar

Lead Sponsor

Maharishi International University

Collaborator

Trials

13

Recruited

1,800+