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A Clinical Study to Evaluate a New Portable Shiro Basti Device for Safe Ayurvedic Treatment

Design Development And Clinical Validation Of A Portable Automated Shiro Basti Device With Integrated Thermoregulation For Safe Ayurvedic Therapy - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/102568
Enrollment
30
Registered
2026-01-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Parul Institute of Ayurved
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age Group of 18 to 70 Years Diagnostic Criteria Health Status Should be Excellent(Score more than 66.60 out of 74) or Good(59.20 to 66.59 out of 74) According to Svasthya Assessment Scale

Exclusion criteria

Exclusion criteria: Systemic Illness Head Injury or Recent Surgery Any Scalp Infection/Pathology

Design outcomes

Primary

MeasureTime frame
To Design, develop & clinically validate a portable automated Shiro Basti device with integrated thermoregulation for safe ayurvedic therapyTimepoint: 4 weeks—

Secondary

MeasureTime frame
To compare the effects of using a Shiro Basti device with the traditional (classical) method of Shiro Basti in a clinical pilot studyTimepoint: Safety Assessment Parameter 1 Incidence of Adverse Events 2 Skin Temperature at Application Site 3 Thermal Comfort Level (VAS) 4 Post-therapy Skin Observation Clincal Efficacy Parameter 1 Relaxation Response 2 Perceived Stress Level 3 Sleep Quality 4 Mood State 5 Cognitive Clarity 6 Heart Rate / HRV 7 Muscle Tension (Scalp/Face) 8 Thermal Comfort This will be assessesd after 1 sitting(Day after Procedure)—

Countries

India

Contacts

Public ContactDr Maitree Vijeshkumar Patel

Parul Institute of Ayurveda

maitri.patel@paruluniversity.ac.in9909831427

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026