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Evaluation of integrated intensive wellness strategy in Type 2 diabetes with high triglycerides

Evaluation of integrated intensive wellness strategy on biophysiological parameters,life style practices and quality of life among adults with Type 2 diabetes mellitus with hypertriglyceridemia - A randomized controlled trial. - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072717
Enrollment
160
Registered
2024-08-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: Integrated Intensive Wellness(IIW) Strategy: IIW Strategy refers to Comprehensive Lifestyle Modification therapy such as Behaviour Change Communication(BCC), Amla Ginger Curry leaves(AG

Sponsors

DrRadhika R
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All registered Type 2 DM 30 to 65 years with the FBS greater than 125mg/dl, HbA1C greater than 6.5 and Triglycerides greater than 130mg/dl to lesser than 250 mg/dl will be included in the study 2. A signed and dated written informed consent prior to admission to the study.

Exclusion criteria

Exclusion criteria: 1.History of any co-morbidities other than hypertension. 2.History of patient on Insulin treatment. 3.Newly registered patient less than one month 4.History of any Amla, ginger and curry leaves allergy. 5.History of Anatomical deformities in Nasal pathway and Extremities. 6.History of specific Psychiatric illness.

Design outcomes

Primary

MeasureTime frame
Statistically significant reduction of mean of HbA1c from baseline to weeks 24 and FBS,TGL,SBP, DBP, Weight, BMI, Waist Circumferance from baseline to week 4, 8,12 and week 24 at p value less than 0.05 level in IIW Strategy than control arm.Timepoint: Six months

Secondary

MeasureTime frame
Statistiscally significant improvement in Lifestyle practices and Quality of life at p value less than 0.05 level in IIW Strategy than Control arm.Timepoint: Six months

Countries

India

Contacts

Public ContactDrNavaneetha M

Pondicherry Institute of Medical Sciences

navamd11176@gmail.com9448159718

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026