NCT07174804

Brief Summary

The goal of this Non-Randomized Control Trial is to evaluate the prevalence of chromosomal translocations in occupationally stressed subjects and the molecular impact of yoga on such translocations and DNA damage response and repair in security guards of Chandigarh Police. The main questions it aims to answer are: Does yoga has any role in alleviating chromosomal translocations in healthy but occupationally stressed subjects? Does practice of yoga has any impact on molecular markers related to DNA damage response and repair before and after Yoga intervention in highly stressed individuals? Researchers will compare Control Group and Yoga group before and after Yoga intervention. Participants will be divided into two groups Control Group and Yoga Group. Yoga Group will be given yoga intervention for 3 months, 5 days a week and for 65 minutes in a day. Control Group will follow their daily routine without following the intervention. Before and after the intervention, blood samples will be collected from the participants of both groups and analysed for chromosomal translocations and DDRR markers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

September 3, 2025

Last Update Submit

September 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of t(14;18) translocations using Nested PCR method

    Both control and yoga group will be assessed for prevalence of chromosomal translocations t(14;18) before and after yoga (IAYT) intervention. This prevalence will be measured as relative band intensity for each individual and will be compared for before and after IAYT intervention, and also for between the groups after intervention.

    3 months

Secondary Outcomes (5)

  • Cohen's Perceived Stress Scale

    3 months

  • Six Letter Cancellation Test (SLCT)

    3 months

  • Trail Making Test (TMT)

    3 months

  • Serum cortisol level using enzyme-linked immunosorbent assay

    3 months

  • Relative Telomere Length using Real-Time PCR

    3 months

Study Arms (2)

IAYT Group (Yoga Group)

EXPERIMENTAL

This group will be formed from highly stressed individuals and will follow yoga protocol as intervention for three months.

Other: Yoga (IAYT) Intervention

Control Group

NO INTERVENTION

This group will be formed from highly stressed individuals and will not follow yoga protocol as intervention.

Interventions

Yoga practice for a period of three months

IAYT Group (Yoga Group)

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals scoring more than 15 points on Cohen's scale. Once these subjects' consent to enrol, each one of them will be coded to maintain anonymity.

You may not qualify if:

  • Individuals with complications in co-morbid conditions like Diabetes, Cirrhosis, etc.
  • Individuals of age less than 25 or more than 60 years.
  • Individuals who do not consent to be a part of this study.
  • Individuals who fail to comply with the yoga protocol in Intervention Group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Translocation, Genetic

Interventions

YogaMethods

Condition Hierarchy (Ancestors)

Chromosome AberrationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy ModalitiesInvestigative Techniques

Study Officials

  • Sheetal Sharma

    Postgraduate Institute of Medical Education & Research, Chandigarh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 3, 2025

First Posted

September 16, 2025

Study Start

November 1, 2021

Primary Completion

February 28, 2022

Study Completion

March 31, 2022

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Age, Occupation, Gender, Neuropsychological Data, Cortisol levels, Relative Telomere Length and chromosomal Translocations

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
September 2026 to December 2026
Access Criteria
Access to individual participant data will be granted to qualified researchers affiliated with academic or non-profit institutions. Requests must include a research proposal describing the purpose of use. Requests will be reviewed by the principal investigator and must comply with local and international data protection regulations. Data will be shared under a data use agreement to ensure confidentiality and non-commercial use.

Locations