Understanding Ayurveda Disease Conditions and Treatment Responses

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06167226
• Other study ID #: CTRI/2021/12/038909
• Status: Completed
• Start date: December 29, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: December 2023
• Source: Ayurai Private Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 497
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients of various diseases visiting the OPD

Exclusion Criteria:

• Pregnancy and lactating females

Related Conditions & MeSH terms

• Arthritis
• Gastric Ulcer
• Neurodegenerative Diseases
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee
• Rheumatoid Arthritis
• Skin Diseases
• Stomach Ulcer

Intervention

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

Locations

Country	Name	City	State
India	SRM Medical College Hospital & Research Centre	Chennai	Tamil Nadu

Sponsors (2)

Lead Sponsor	Collaborator
Ayurai Private Limited	SRM Medical College Hospital & Research Centre

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Serum Urea	Measures urea, which is a investigation to measure the abnormality in kidney function	12 weeks
Primary	Serum creatinine	Measures creatinine, which is a investigation to measure the abnormality in kidney function	12 weeks
Primary	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
Primary	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
Secondary	Pulse Plethysmography signals (PPG) - Finger PPG sensor	PPG is measured to identify pulse wave form changes before and after treatment	12 weeks