Understanding Ayurveda Disease Conditions and Treatment Responses

NCT06167226 | Completed

• 1 other identifier: CTRI/2021/12/038909
• Study Type: observational
• Target: 497
• Locations: 1 country
• Sites: 1

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

Conditions

Type2diabetes; Rheumatoid Arthritis; Osteo Arthritis Knee; Skin Diseases; Gastric Ulcer; Neurodegenerative Diseases

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

Secondary Outcomes (1)

• Pulse Plethysmography signals (PPG) - Finger PPG sensor

  12 weeks

Interventions

Personalized Ayurveda treatment protocol DRUG

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

Also known as: No other intervention name

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of various diseases visiting the OPD

You may qualify if:

• Patients of various diseases visiting the OPD

You may not qualify if:

• Pregnancy and lactating females

Sponsors & Collaborators

• Ayurai Private Limited: lead
• SRM Medical College Hospital & Research Centre: collaborator

Study Sites (1)

SRM Medical College Hospital & Research Centre

Chennai, Tamil Nadu, 603203, India

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Arthritis, Rheumatoid; Skin Diseases; Stomach Ulcer; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Nervous System Diseases

Study Officials

• RC Sathish kumar

  SRM Medical College Hospital & Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: December 12, 2023
• Study Start: December 29, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publishing and for 3 years
• Access Criteria: Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

Locations

IN (1)