EFFECTIVENESS OF HOMOEOPATHIC MOTHER TINCTURES AS ADD-ON THERAPY IN ADULTS SCREENED FOR INSULIN RESISTANCE BY TyG-BMI INDEX: AN OPEN-LABEL RANDOMIZED TRIAL
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- PARTICIPANTS RECEIVING HOMOEOPATHIC MOTHER TINCTURES ALONG WITH INDIVIDUALIZED HOMOEOPATHIC MEDICINES ARE EXPECTED TO SHOW A GREATER REDUCTION IN TYG-BMI INDEX COMPARED TO THOSE RECEIVING INDIVIDUALIZED HOMOEOPATHIC TREATMENT ALONE
研究概览
简要总结
AIM
To ascertain the effectiveness of Homoeopathic mother tinctures (Crataegus oxyacantha and Berberis vulgaris) when given along with individualised medicine in altering the parameter of TyG-BMI index in adults screened for insulin resistance.
OBJECTIVES
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To assess the effectiveness of Homoeopathic individualised medicine by comparing pre and post reports of TyG-BMI index in adults screened for insulin resistance.
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To assess the effectiveness of Homoeopathic mother tincture Crategus oxycantha when given along with individualised medicine by comparing pre and post reports of TyG-BMI index in adults screened for insulin resistance.
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To assess the effectiveness of Homoeopathic mother tincture Berberis vulgaris when given along with individualised medicine by comparing pre and post reports of TyG-BMI index in adults screened for insulin resistance.
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To assess and compare the effectiveness of Homoeopathic mother tinctures (Crataegus oxyacantha and Berberis vulgaris) when given along with individualised medicine by comparing pre and post reports of TyG-BMI index in adults screened for insulin resistance.
JUSTIFICATION OF STUDY
Given the rising global and national burden of insulin resistance (IR) and its progression to chronic conditions such as type 2 diabetes, cardiovascular disease, and MASLD, there is an urgent need to explore safe, accessible, and cost-effective adjunctive therapies. Homoeopathic mother tinctures, particularly Crataegus oxyacantha and Berberis vulgaris, have shown promising lipid-modulating and insulin-sensitizing effects in previous studies, but their efficacy in Insulin Resistance (IR) using validated endpoints like the TyG-BMI index remains underexplored.
This study addresses a key research gap by being among the first randomized controlled trials to evaluate the impact of these mother tinctures on TyG-BMI levels in individuals with insulin resistance. It leverages TyG-BMI as a practical, non-invasive screening and monitoring tool suitable for primary care and low-resource settings. If effective, these remedies could offer a well-tolerated and integrative approach to improving insulin sensitivity, with minimal adverse effects and greater patient compliance. By combining individualized constitutional homoeopathy with organ-targeted mother tinctures, this study aligns with the growing global interest in complementary and alternative medicine (CAM). It aims to generate evidence-based support for the inclusion of homoeopathic interventions in metabolic care, ultimately contributing to early intervention, enhanced patient outcomes, and holistic disease management.
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing to provide informed written consent.
- •BMI more than or equals to 23 kg per m2
- •Impaired fasting plasma glucose more than or equals to 100mg per dl or PP(2h) and blood glucose random more than or equals to 140mg per dl or HbA1c more than or equals to 5.7 percent
- •Impaired fasting triglycerides more than or equals to 150mg per dl
- •Blood pressure more than or equals to 140 over 90 mm of Hg
- •Diagnosed with insulin resistance, defined by elevated TyG-BMI index (based on TyG-BMI Quartiles).
- •Those already taking medications that directly alter insulin resistance (e.g., metformin, pioglitazone, statins, corticosteroids, weight-loss drugs) still TyG-BMI index is high.
- •Willing and able to comply with treatment, follow-up visits, and protocol requirements.
排除标准
- •Patients unwilling to provide informed written consent or unable to follow up regularly or comply with the protocol.
- •Patients with clinically unstable or advanced organ diseases.
- •Pregnant or lactating women, due to hormonal effects and ethical limitations.
- •Patients with acute infections, ongoing febrile illnesses, or current hospitalization.
- •Individuals with substance abuse, severe psychiatric illness, or cognitive impairment affecting compliance.
- •Known allergy to Crataegus or Berberis preparations.
- •Participants enrolled in any other clinical trial.
结局指标
主要结局
PARTICIPANTS RECEIVING HOMOEOPATHIC MOTHER TINCTURES ALONG WITH INDIVIDUALIZED HOMOEOPATHIC MEDICINES ARE EXPECTED TO SHOW A GREATER REDUCTION IN TYG-BMI INDEX COMPARED TO THOSE RECEIVING INDIVIDUALIZED HOMOEOPATHIC TREATMENT ALONE
时间窗: PRE- AND POST-SCORES WILL BE ASSESSED BASED ON ALTERATIONS IN TYG-BMI VALUES ACROSS QUARTILES (Q1–Q4) AT THE END OF 3 MONTHS
次要结局
- AT THE END OF STUDY WE EXPECT THAT CRATAEGUS OXYACANTHA AND BERBERIS VULGARIS HOMOEOPATHIC MOTHER TINCTURES NOT ONLY MANAGED INSULIN RESISTANCE BUT ALSO ITS COMORBIDITIES(12 MONTHS)
- MOTHER TINCTURE DOSES ARE EMPIRICALLY DERIVED AND NOT YET RIGOROUSLY VALIDATED; THEREFORE, THIS STUDY WILL CONTRIBUTE TOWARD DOSE VALIDATION. THE TRIAL IS EXPECTED TO GENERATE DATA TO SUPPORT FUTURE DOSE–RESPONSE EVALUATIONS AND FACILITATE EVIDENCE-BASED REFINEMENT OF MOTHER TINCTURE USE IN HOMOEOPATHY AS AN ADD-ON THERAPY.(12 MONTHS)
研究者
Dr PARIDHI JAIN
Dr MPK HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE