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NCT Number: NCT06167226

Understanding Ayurveda Disease Conditions and Treatment Responses

The goal of this observational study is to assess Prakriti & Vikriti in patients visiting OPD of IIISM department, SRM hospital.

The main question[s] it aims to answer are:

* To evaluate Prakriti & Vikriti of patients using Prakriti & Vikriti questionnaire and with digital devices * To correlate the determined Prakriti and Vikriti with the doctor's assessment along with clinical and biochemical parameters Participants will be advised to follow the treating physician's advice on medicines

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Key information

Conditions

Type2diabetes Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Digestive System Diseases Duodenal Diseases Gastric Ulcer Gastrointestinal Diseases Immune System Diseases Intestinal Diseases Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurodegenerative Diseases Osteo Arthritis Knee Peptic Ulcer Rheumatic Diseases Rheumatoid Arthritis Skin Diseases Skin and Connective Tissue Diseases Stomach Diseases Stomach Ulcer

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SRM Medical College Hospital & Research Centre

Chennai, Tamil Nadu, 603203, India

About this study

The Ayurveda is an ancient documented medical system originated in India. The Ayurveda stratified humans into 7 broad categories based on the phenotype features viz. Vata, Pitta, Kapha, Vatapitta, Vatakapha, Kaphapitta and Vatapittakapha Prakriti types. Also, the features of the disease conditions are clearly described based on the predominance of Vata, Pitta and Kapha or its combinations. Presently, the identification of Prakriti type and Vikriti status are basically subjective assessment. This study proposes to integrate the subjective assessment with objective digital signal parameters. This digital signatures would be useful in ML / AI based assessment and prediction of Prakriti type and Vikriti status of the patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of various diseases visiting the OPD

Exclusion criteria

  • Pregnancy and lactating females

Treatment and study plan

Personalized Ayurveda treatment protocol

Drug

The treating physician decided and advised personalized Ayurveda treatment protocol based on disease and patient's condition

Other names: No other intervention name

Primary outcomes

  1. Change from baseline in Complete blood count at 12 week

    Time frame: 12 weeks

    complete blood count, which includes red blood cell count, neutrophil count, eosinophil count, basophil count, lymphocyte count, monocyte count, and platelet count is a standard investigation to measure the abnormality in blood cells

  2. Serum Urea

    Time frame: 12 weeks

    Measures urea, which is a investigation to measure the abnormality in kidney function

  3. Serum creatinine

    Time frame: 12 weeks

    Measures creatinine, which is a investigation to measure the abnormality in kidney function

  4. Lipid Profile

    Time frame: 12 weeks

    Lipid profile test includes Total cholesterol, LDL, HDL, Triglycerides, and non-HDL is a investigation to measure the abnormality in lipids

  5. Cytokines (TNF- alpha, IFN-gamma, IL-1, IL-4, IL-6, IL-10)

    Time frame: 12 weeks

    Cytokines are inflammatory markers, measured to identify treatment effect in inflammation

Secondary outcomes

  1. Pulse Plethysmography signals (PPG) - Finger PPG sensor

    Time frame: 12 weeks

    PPG is measured to identify pulse wave form changes before and after treatment

Sponsors and collaborators

Lead sponsor

Ayurai Private Limited

Industry

Collaborators

  • SRM Medical College Hospital & Research Centre

Registry information

Official study title

Prediction of Ayurveda Prakriti and Vikriti Using Automatic Questionnaire and Digital Sensors

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 12, 2023
Registry last updated
Dec 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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