Understanding Ayurveda Disease Conditions and Treatment Responses

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

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

Study Overview

• Status: Completed
• Conditions: Skin Diseases; Rheumatoid Arthritis; Neurodegenerative Diseases; Osteo Arthritis Knee; Gastric Ulcer; Type2diabetes
• Intervention / Treatment: Drug: Personalized Ayurveda treatment protocol

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 497

Contacts and Locations

Study Locations

• India
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 603203
      • SRM Medical College Hospital & Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients of various diseases visiting the OPD

Description

Inclusion Criteria:

• Patients of various diseases visiting the OPD

Exclusion Criteria:

• Pregnancy and lactating females

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Complete blood count at 12 week	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	12 weeks
Lipid Profile	Lipid profile test includes Total cholesterol, LDL, HDL, Triglycerides, and non-HDL is a investigation to measure the abnormality in lipids	12 weeks
Cytokines (TNF- alpha, IFN-gamma, IL-1, IL-4, IL-6, IL-10)	Cytokines are inflammatory markers, measured to identify treatment effect in inflammation	12 weeks
Serum Urea	Measures urea, which is a investigation to measure the abnormality in kidney function	12 weeks
Serum creatinine	Measures creatinine, which is a investigation to measure the abnormality in kidney function	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse Plethysmography signals (PPG) - Finger PPG sensor	PPG is measured to identify pulse wave form changes before and after treatment	12 weeks

Collaborators and Investigators

• Sponsor: Ayurai Private Limited
• Collaborators: SRM Medical College Hospital & Research Centre
• Investigators: Principal Investigator: RC Sathish kumar, SRM Medical College Hospital & Research Centre

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: November 18, 2023
• First Submitted That Met QC Criteria: December 9, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Gastrointestinal Diseases; Stomach Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Intestinal Diseases; Peptic Ulcer; Duodenal Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Neurodegenerative Diseases; Skin Diseases; Stomach Ulcer
• Other Study ID Numbers: CTRI/2021/12/038909

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices)
• IPD Sharing Time Frame: After publishing and for 3 years
• IPD Sharing Access Criteria: Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No