Understanding Ayurveda Disease Conditions and Treatment Responses

Completed

• Conditions: Rheumatoid Arthritis; Osteo Arthritis Knee; Skin Diseases; Type2diabetes; Gastric Ulcer; Neurodegenerative Diseases

• Registration Number: NCT06167226
• Lead Sponsor: Ayurai Private Limited

Brief Summary

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

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 Timeline

• Study Start: 2021-12-29
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31
• Study First Submitted: 2023-11-18
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-09
• Study First Posted: 2023-12-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 497

Inclusion Criteria

• Patients of various diseases visiting the OPD

Exclusion Criteria

• Pregnancy and lactating females

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

SRM Medical College Hospital & Research Centre; 🇮🇳 Chennai, Tamil Nadu, India