Currently accepted at: JMIR Research Protocols
Date Submitted: Apr 23, 2026
Date Accepted: Aug 11, 2026
This paper has been accepted and is currently in production.
It will appear shortly on 10.2196/99224
The final accepted version (not copyedited yet) is in this tab.
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Evaluation of comparative efficacy of a thermo-regulated automated irrigation device conceptualized from Aṣhṭanga Hṛdaya principles versus traditional Manya Basti in Manyashool (Cervical Spondylosis): a randomized controlled trial protocol.
ABSTRACT
Background:
Manyashool, a Vata-dominant musculoskeletal disorder in Ayurveda, closely correlates with cervical spondylosis in contemporary medicine and is characterized by neck pain, stiffness, and restricted movement. Manya Basti is a classical localized Panchakarma procedure widely used for its management through the combined effects of Snehana and Swedana. However, the conventional method is limited by poor temperature control, operator dependency, oil leakage, contamination risk, and lack of procedural standardization. To address these limitations, the present study proposes a thermo-regulated automated irrigation (TAI) device conceptualized from Aṣhṭanga Hṛdaya principles.
Objective:
We aim to compare the efficacy of a newly developed thermoregulated automated irrigation (TAI) device with the traditional manya basti method in the management of Manyaśūla, and the objective is to evaluate the comparative efficacy of a newly developed TAI device against the traditional Manya Basti method in the management of Manyashool.
Methods:
This study is designed as a prospective, randomized, open-label, standard-controlled superiority trial at a tertiary Ayurvedic care center in India. The protocol has two phases. Phase I includes the design, development, testing, and refinement of the TAI device. Phase II involves clinical validation in 60 eligible patients with Manyashool, randomized equally into two groups: traditional Manya Basti and TAI device-assisted Manya Basti. Both groups will receive treatment for seven consecutive days using the same medicated oil and temperature range. Primary outcome will be reduction in neck pain assessed by Visual Analogue Scale. Secondary outcomes include Neck Disability Index, cervical range of motion, patient comfort, procedural standardization, temperature stability, and oil wastage.
Results:
The study is expected to demonstrate that TAI device-assisted Manya Basti provides comparable or superior pain relief and functional improvement compared with the traditional method, while also offering better temperature regulation, reduced oil wastage, improved comfort, and lower operator dependency.
Conclusions:
This protocol may generate preliminary evidence supporting the feasibility, effectiveness, and standardization of device-assisted Panchakarma, thereby integrating classical Ayurvedic principles with modern therapeutic innovation. Clinical Trial: Clinical trial registration: CTRI/2026/03/106247 registered on 16-03 2025, with the Clinical Trials Registry – India (CTRI), accessible at https://ctri.nic.in/Clinicaltrials. IEC Approval No.: MGACHRC / IEC / Feb-2026 / 1019
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