跳至主要内容
临床试验/CTRI/2025/09/094203
CTRI/2025/09/094203尚未招募不适用

Managing Psychological Well-being in Patients with Coronary Heart Disease through an Intervention Package of Nature Cure, Yoga, and Counseling

Nisargopchar Yog Manav Utthan Cheritable Trust1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Outcome name: Psychological Well-Being (PWBS; Sisodia & Chaudhary) total score

研究概览

简要总结

Coronary heart disease CHD is often accompanied by psychological distress, which adversely impacts quality of life and clinical outcomes. This randomized controlled trial is designed to evaluate whether an integrative 12-week program of Nature Cure, Yoga, and Counseling can enhance psychological well-being and improve selected cardiometabolic markers in adults with CHD in Gujarat.

The study will enroll 60 adults (30–70 years) diagnosed with CHD within the last 12 months and currently on standard medication. Participants will be randomized into two groups:

  • Group 1 (Control) Standard medication and usual care.
  • Group 2 (Intervention) Standard medication plus a 12-week integrative program comprising one in-person session per week (Yoga practices, Nature Cure therapy, and counseling), two additional online sessions per week (Yoga and counseling), and continuous online support as per participant’s needs.

The Yoga module includes asanas, breathing practices, relaxation, and meditation. Nature Cure interventions include diet therapy based on naturopathy principles, selected hydrotherapy (e.g. hot & cold foot bath, cold spinal compress), ghee foot therapy, walking, and lifestyle counseling with dietary reinforcement.

Assessments will be conducted at baseline and week 12.

  • Primary Outcome: Change in Psychological Well-Being Scale score.
  • Secondary Outcomes: Blood pressure (systolic and diastolic) serum total cholesterol, serum triglycerides, and adverse events.

Randomization will use computer-generated variable permuted blocks, with allocation concealed in sequentially numbered opaque envelopes. Laboratory staff and the data analyst will remain blinded to group codes. Ethics approval has been obtained, and informed consent will be taken from all participants prior to enrollment.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Subjects between 30 yrs.
  • of age of both the genders.
  • Subjects having CHD within last 1 yrs and are on medication.
  • Not taken Nature Cure & Yoga Treatment previously.

排除标准

  • Uncontrolled CHD
  • Subjects with, cerebral complications, renal disease or on Steroids and other critical Medical condition.
  • Patient having Psychiatric illness,
  • Subjects already practicing yoga therapy and Nature Cure treatment.
  • Pregnant women
  • Disabled person.

结局指标

主要结局

Outcome name: Psychological Well-Being (PWBS; Sisodia & Chaudhary) total score

时间窗: Baseline/12 week post intervention

Measure/units: PWBS standardized score

时间窗: Baseline/12 week post intervention

次要结局

  • 1.Systolic Blood Pressure (SBP) Units: mmHg(2.Diastolic Blood Pressure (DBP) Units: mmHg)

研究者

发起方
Nisargopchar Yog Manav Utthan Cheritable Trust
申办方类型
Other [ngo]
责任方
Principal Investigator
主要研究者

Rupal Dilipbhai Gandhi

Lakulish Yog University

研究点 (1)

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