Brahmi-Gotukola Oil Foot Massage for Insomnia

(BG-SLEEP Trial)

SG
SS
Overseen BySangeetha Sharma, BAMS,MD (Ayu), PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a nightly 5-minute foot massage with Brahmi-Gotukola oil can improve sleep for women aged 40 to 55 during perimenopause, a time when periods change and sleep issues often arise. The trial will compare this oil to sesame oil to determine which is more effective for sleep and mood. Participants will massage their feet nightly for two weeks and record their sleep in a log. Women experiencing irregular periods and sleep difficulties during perimenopause may be suitable for this trial. As an unphased trial, this study provides an opportunity to explore a natural remedy for enhancing sleep and mood during perimenopause.

Will I have to stop taking my current medications?

Yes, if you are using any anxiolytics (medications for anxiety) or antidepressants, you cannot participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Brahmi and Gotu Kola, the main ingredients in Brahmi-Gotukola oil, are generally safe in traditional practices like Ayurvedic massages. These herbs are known for their calming effects and ability to help the body manage stress, promoting relaxation and better sleep. Although specific data on side effects from using Brahmi-Gotukola oil in foot massages is lacking, these herbs have a long history of safe use in traditional medicine.

Sesame oil, used for comparison, is also considered safe for skin application and is frequently used in massages. There are no major reports of side effects from using sesame oil in these treatments. Overall, both oils appear well-tolerated based on traditional uses and available information.12345

Why are researchers excited about this trial?

Researchers are excited about the Brahmi-Gotukola oil foot massage for insomnia because it offers a unique, natural approach compared to standard sleep aids like prescription medications or over-the-counter sleep pills. Unlike these conventional treatments, which often involve chemicals and can have side effects, this method utilizes a blend of Brahmi and Gotukola oils, both known in Ayurveda for their calming properties. The treatment is also distinctive in its delivery method—a soothing foot massage—promoting relaxation and potentially improving sleep quality without the need for ingesting substances. This approach could provide a more holistic and gentle alternative for those seeking relief from insomnia.

What evidence suggests that this trial's treatments could be effective for perimenopausal sleep problems?

Research shows that Brahmi-Gotukola oil massages might improve sleep quality. Brahmi (also called Bacopa) and Gotu Kola are herbs traditionally used in Ayurveda for their calming effects and support of mental health. Some studies suggest these herbs can reduce anxiety and promote relaxation, potentially leading to better sleep. In this trial, one group of participants will receive a foot massage with Brahmi-Gotukola oil, while another group will receive a foot massage with sesame oil, often used in Ayurvedic practices for its soothing properties. Although direct research on these oils specifically for foot massages is limited, the herbs and sesame oil themselves have been linked to improved mood and fewer sleep problems.12356

Who Is on the Research Team?

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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.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants perform a nightly 10-minute foot massage using either Brahmi-Gotukola oil or sesame oil for 14 consecutive days

2 weeks
Self-administered at home

Follow-up

Participants complete follow-up questionnaires to assess the persistence of improvements in sleep and mood

2 weeks
Questionnaires completed in the 3rd and 4th weeks

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?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Brahmi-Gotukola oil Padabhyanga( foot massage)Experimental Treatment1 Intervention
Group II: Sesame oil padabhyanga ( foot massage)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Saipriya Gowrishankar

Lead Sponsor

Maharishi International University

Collaborator

Trials
13
Recruited
1,800+

Citations

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