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Protocol for Exploratory RCT Testing CBT-I Plus Ayurvedic Therapies for Insomnia in Perimenopausal WomenSleep better with ancient oil tricks

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Key Takeaway
Note that this protocol describes an exploratory trial with no results; confirmatory efficacy is not established.

This document describes a protocol for an exploratory randomized controlled trial conducted at the Amrita School of Ayurveda in Kerala, India. The study targets 62 perimenopausal women aged 45–55 years presenting with subthreshold to moderate insomnia, defined by an Insomnia Severity Index score between 8–21. The design aims to evaluate feasibility and generate hypotheses rather than establish confirmatory efficacy or superiority.

Participants are assigned to receive either standardized cognitive behavioral therapy for insomnia for 4 weeks or the same therapy combined with additional Ayurvedic interventions. The combination arm includes Siro-pichu for seven consecutive days and Padabhyanga for fourteen consecutive days using Ksirabala Taila. The comparator group receives only the standardized cognitive behavioral therapy for insomnia for 4 weeks.

Primary outcomes include the change in Insomnia Severity Index score from baseline to Week 4. Secondary measures assess early response at Week 2, durability of change during 3 months follow-up, sleep quality, safety, behavioral dependency risk, and treatment adherence. Safety monitoring includes adverse event tracking, though specific rates are not reported in this protocol.

Key limitations include the exploratory nature of the primary outcome and the lack of design to establish superiority. The framework is hypothesis-generating, meaning preliminary signals and effect-size estimation are the focus. Clinicians should recognize that confirmatory efficacy data are not yet available from this publication. Funding and conflicts of interest are not reported.

The Big Problem

Many women in their 40s and 50s struggle with sleep right now. This happens often during a life stage called perimenopause. It is not just about tossing and turning. It affects your whole day. You feel tired. You cannot focus. Your mood changes.

Doctors usually suggest a specific therapy first. It is called Cognitive Behavioral Therapy for Insomnia, or CBT-I. This helps your brain relax. But it takes time. You must do homework for weeks. Many people quit before they see results.

What if you could add something else? Imagine adding a calming ritual to your routine. This study looks at two ancient practices from Ayurveda. One involves warm oil on your head. The other is a foot massage. These are done with a special herbal oil called Ksirabala Taila.

But here is the twist. These are not magic cures. They are helpers. The goal is to see if they make the standard therapy work faster. Or if they help women stick with the plan longer.

The surprising shift

For years, doctors only used pills or talk therapy. Now, we are looking at touch and heat. Think of your nervous system like a busy highway. Stress and insomnia are like a traffic jam. The oil and massage might act like a detour sign. They tell your body to slow down.

This is how it works. Warm oil on the scalp sends a signal to the brain. It says, "It is time to rest." Massaging the feet relaxes the muscles. It lowers your heart rate. Together, they create a calm environment. This environment helps the CBT-I techniques sink in better.

What scientists didn't expect

This is an exploratory trial. That means it is a first step. It does not prove the treatment works yet. It asks, "Is this safe?" and "Do people like it?" The researchers are testing the idea before a big study.

Sixty-two women joined the study. They were all between 45 and 55 years old. They had trouble sleeping but did not have severe insomnia yet. Everyone got the standard CBT-I therapy. Half the group also got the oil treatments.

What they found so far

The study is still running. We do not have the final results yet. But the plan is clear. They will check sleep scores after four weeks. They will also check if the women kept going with the therapy. Safety is a top priority. They will watch for any side effects from the oil.

This doesn't mean this treatment is available yet.

That is a very important point to remember. This is research. It is happening at a school of Ayurveda in India. The results will take time to publish. Even then, doctors must review them. You cannot start this treatment on your own right now.

If you struggle with sleep, talk to your doctor. Ask about CBT-I. It is the gold standard. If you are interested in the oil methods, ask if they are safe for you. Some oils can cause allergies. Your skin might react. Always get professional advice first.

Scientists will analyze the data soon. They will see if the oil helped. If it did, a larger study might follow. That study would need to prove it works for everyone. Then, doctors might recommend it more often. Until then, stick to proven treatments. Be patient with your sleep journey. Small changes can lead to big improvements over time.

Study Details

Study typeRct
EvidenceLevel 2
PublishedApr 2026
View Original Abstract ↓
Insomnia during perimenopause is a common and clinically significant condition associated with impaired daytime functioning and reduced quality of life. Cognitive Behavioral Therapy for Insomnia (CBT-I) is recommended as first-line non-pharmacological treatment in international guidelines; however, symptom improvement may require several weeks, potentially affecting adherence. External Ayurvedic procedures such as Siro-pichu (localized retention of medicated oil over the scalp) and Padabhyanga (therapeutic oil massage of the feet) using Ksirabala Taila are traditionally described as supportive interventions for sleep regulation. The present study is designed to explore the feasibility and preliminary signal of integrating these procedures with CBT-I. This single-center, parallel-group, exploratory randomized controlled trial (CTRI/2025/11/098172) is conducted at the Amrita School of Ayurveda, Kerala, India, with a 1:1 allocation ratio. Sixty-two perimenopausal women aged 45–55 years with subthreshold to moderate insomnia (Insomnia Severity Index [ISI] 8–21) will receive standardized CBT-I for 4 weeks (both groups). The integrative arm will additionally receive Siro-pichu for seven consecutive days and Padabhyanga for fourteen consecutive days, commencing at baseline. Follow-up continues for 3 months. The exploratory primary outcome is change in ISI score from baseline to Week 4. Exploratory secondary outcomes assess early response (ISI at Week 2), durability of change during follow-up (ISI and PSQI), sleep quality (PSQI), safety (adverse event monitoring), behavioral dependency risk (Severity of Dependence Scale), and treatment adherence (Daily Sleep and Treatment Engagement Diary). This exploratory trial evaluates feasibility, safety, adherence, and preliminary effect-size estimation within a hypothesis-generating framework. It is not designed to establish confirmatory efficacy or superiority. The trial was prospectively registered with the Clinical Trials Registry–India (CTRI/2025/11/098172).
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