| CTRI Number |
CTRI/2025/07/092125 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring The Relationship Between Obesity And Bone Health |
|
Scientific Title of Study
|
An Obvservational Study To Evaluate The Relationship Between Sthaulyata And Asthisarata By Using BMD, Serum Calcium, Serum ALP |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyoti Suda |
| Designation |
MD Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh |
| Address |
Department of Kriya Sharira Ayurvedic and Unani Tibbia College and hospital Ajmal Khan Rd Block 56 Karol Bagh New Delhi-110005 India
Central
DELHI
110005
India |
| Phone |
7627097978 |
| Fax |
|
| Email |
jyotisuda79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Rajan |
| Designation |
Head of Department |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh |
| Address |
Department of Kriya Sharira Ayurvedic and Unani Tibbia College and hospital Ajmal Khan Rd Block 56 Karol Bagh New Delhi-110005 India
Central
DELHI
110005
India |
| Phone |
9354925026 |
| Fax |
|
| Email |
sujataa.rajan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata Rajan |
| Designation |
Head of Department |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh |
| Address |
Department of Kriya Sharira Ayurvedic and Unani Tibbia College and hospital Ajmal Khan Rd Block 56 Karol Bagh New Delhi-110005 India
Central
DELHI
110005
India |
| Phone |
9354925026 |
| Fax |
|
| Email |
sujataa.rajan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College and Hospital |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Kriya Sharira Ayurvedic and Unani Tibbia College and hospital Ajmal Khan Rd Block 56 Karol Bagh New Delhi-110005 India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jyoti Suda |
Ayurvedic and Unani Tibbia College and Hospital |
OPD No. 20, Department of Kriya
Sharira
Central
DELHI |
7627097978
jyotisuda79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Ayurvedic and Unani Tibbia College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Obesity |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: NIL, Reference: NIL, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 0(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 0 Days, anupAna/sahapAna: No, Additional Information: OBSERVATIONAL STUDY. NO MEDICINES GIVEN. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: NIL, Reference: NIL, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 0(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 0 Days, anupAna/sahapAna: No, Additional Information: OBSERVATIONAL STUDY. NO MEDICINES GIVEN. |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. 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]
2. No history of serious illness or disease.
3. Subjects must be able to provide the required information about health history. |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from congenital anomalies and hereditary Diseases.
2. 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.
3. Subjects suffering from Type-I DM or Type-II DM.
4. Subjects suffering from Thyroid Dysfunction
5. Taking treatment for major psychiatric problems. Illness necessitating long term drug treatment (Rheumatoid arthritis , Diabetes Mellitus , Psyco-neuro endocrinal disorder , TB, AIDS)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Correlation between Sthaulyata and Asthisarata. |
At baseline only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The Correlation between Sthaulyata & Serum Calcium levels.
The Correlation between Sthaulyata & Serum Alkaline Phosphatase (ALP) levels. |
At baseline only |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |