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Clinical Trials/CTRI/2025/07/092125
CTRI/2025/07/092125Not yet recruitingNot Applicable

An Obvservational Study To Evaluate The Relationship Between Sthaulyata And Asthisarata By Using BMD, Serum Calcium, Serum ALP

Ayurvedic and Unani Tibbia College and Hospital1 site in 1 country50 target enrollmentStarted: August 11, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
The Correlation between Sthaulyata and Asthisarata.

Study Overview

Brief Summary

Obesity, A chronic condition driven by excess calories intake and sedentary habits, increases fat tissue, alters calcium metabolism (elevating Serum Calcium and Alkaline Phosphatase) and disrupts bone remodeling, raising risks for fractures, diabetes, cardiovascular diseases and joints problems.

In Ayurveda, maintaining strong Dhatus (tissues), especially Asthi Dhatu (bone tissue) is essential for overall immunity and health. Qualitative assessments of Dhatu Sarata have been shown to correlate significantly with modern measures like BMD, suggesting and integrative diagnostic potential.

RESEARCH QUESTION

Is there any correlation between Sthoulyata and Asthisarata in human individuals?

MATERIALS AND METHODS

Study Type: Observational

Timing:      Cross-sectional

Sampling Method: Simple Random

Sample Size:         50 (25 Males & 25 Females)

Number of Groups: One

Selection of Subject: A and U Tibbia College and Hospital (OPD/ IPD)

Study Duration: 90 days (3 Months)

All the 50 subjects will be selected by keeping in mind, the signs and symptoms of medovridhi (sthoulayata) and BMI (Screening of subjects will be done once. If any disease condition is observed during the screening, such individuals should be referred for the medical management to the appropriate healthcare facilities).

For the enrolled subjects, Asthisarata will be assessed as by using Ayusoft or validated proforma/questionnaire. Serum Calcium, Serum ALP and BMD will be investigated.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Subjects having BMI more than or equal to 25 kg/m2 and less than 30 kg/m2 Underweight (less than 18.5) ; Normal (18.5-24.9) ; Overweight (25-29.9) ; Obesity (30 or more) [WHO]
  • No history of serious illness or disease.
  • Subjects must be able to provide the required information about health history.

Exclusion Criteria

  • Patients suffering from congenital anomalies and hereditary Diseases.
  • Vital signs out of reference range : Blood pressure more than 150/100 mmHg Oral temperature more than 37.6°C Pulse rate higher than 100 bpm.
  • Subjects suffering from Type-I DM or Type-II DM.
  • Taking treatment for major psychiatric problems.
  • Illness necessitating long term drug treatment (Rheumatoid arthritis , Diabetes Mellitus , Psyco-neuro endocrinal disorder , TB, AIDS).

Outcomes

Primary Outcomes

The Correlation between Sthaulyata and Asthisarata.

Time Frame: At baseline only

Secondary Outcomes

  • The Correlation between Sthaulyata & Serum Calcium levels.

Investigators

Sponsor
Ayurvedic and Unani Tibbia College and Hospital
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Jyoti Suda

Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh

Study Sites (1)

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