A Randomized Clinical Study To Evaluate Efficacy Of Chitrakadi Churna & Lifestyle Management In Prediabetes With Special References To HbA1C.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Reduction in HbA1C levels from baseline, indicating improvement in glycemic control among prediabetes individuals
研究概览
简要总结
TITLE OF DISSERTATION
A RANDOMIZED CLINICAL STUDY TO EVALUATE EFFICACY OF CHITRAKADI CHURNA & LIFESTYLE MANAGEMENT IN PREDIABETES WITH SPECIAL REFERENCE TO HBA1C.
Background
Prediabetes is an intermediate metabolic state between normoglycemia and Type 2 Diabetes Mellitus (T2DM), characterized by impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT). It is a significant public health concern due to its high prevalence and the risk of progression to T2DM and related complications such as cardiovascular diseases, nephropathy, and neuropathy. Lifestyle modifications, including diet and exercise, are the cornerstone of prediabetes management. However, maintaining long-term adherence to lifestyle changes is challenging for many individuals.
Ayurveda offers several herbal formulations with potential hypoglycemic, insulin-sensitizing, and metabolism-enhancing properties. Chitrakadi Churna, known for its deepana (digestive stimulant) and pachana (carminative) effects, may help improve metabolic function and regulate blood sugar levels. However, there is a lack of robust clinical evidence comparing Chitrakadi Churna with conventional lifestyle interventions for prediabetes management.
Purpose of the Trial
This study aims to evaluate and compare the efficacy of Chitrakadi Churna combined with lifestyle modifications versus lifestyle modifications alone in prediabetes management. Specifically, the objectives are:
OBJECTIVES: -
PRIMARY OBJECTIVE-
• To Study & Compare effect of Chitrakadi Churna and Lifestyle Management In Prediabetes w.s.r to HbA1C.
SECONDARY OBJECTIVES-
• To Study the Effect of Chitrakadi Churna In The Management Of Prediabetes w.s.r. To HbA1C.
• To Study the Effect of Lifestyle Management On Prediabetic Patients w.s.r HbA1C.
• To assess the effect of chitrakadi churna & lifestyle management on body mass index (BMI) and waist-to-hip ratio in Prediabetes.
RESEARCH QUESTIONS-
1. Is Chitrakadi Churna is effective in themanagement of Prediabetes w.s.r HbA1C?
2. Is the effect of Chitrakadi Churna is significant than lifestyle management in prediabetes w.s.r to HbA1C?
HYPOTHESIS-
NULL HYPOTHESIS- There is no significant difference between the efficacy of Chitrakadi Churna and lifestyle management in prediabetes w.s.r. HbA1C.
ALTERNATIVE HYPOTHESIS- - There is a significant difference between the efficacy of Chitrakadi Churna and lifestyle management in prediabetes w.s.r. HbA1C
SUBJECTIVE CRITERIA
1. Prabhutmutrata (polyuria)
2. Atipipasa(polydipsia)
3. Atikhudha(polyphagia)
4. Hastapadataladaha (burning sensation in hand & feet)
5. Nidra adhikya (excessive sleep)
6. Alasya (laziness)
7. Avilmutrata
8. Mukha shosh (dryness in the mouth)
9. Sheet priyata (liking of cold things)
10. Madhuryamaasyata (sweet taste in mouth)
OBJECTIVE ASSESSMENT –
1. Weight
2. BMI (Body Mass Index)
3. WAIST-HIP RATIO: - The WHO advises that a healthy WHR is: 0.85 or less for women. 0.9 or less for men.
4. 4.HBA1C
5. FBS (Fasting Blood Glucose)
6. PPBS (Post Prandial Blood Glucose)
7. Fasting Urine sugar
8. Post Prandial Urine sugar.
Materials
Group A: - chitrakadi churna and lifestyle management
Chitraka, Amalaki, Bibhitaki, Haritaki, Daruharidra, Indrayava
Dose- 3gm before food with warm water thrice a day.
Group B: - lifestyle management
Will be suggested to every subject & compliance will be recorded monthly.
Sample size: -
Considering a 20% dropout rate though a sample size of 82, we proposed to enroll 100 subjects to get 82 evaluable cases.
Statistical analysis
-All observations will be noted in the observation table.
-Depending upon the Observation, Statistical analysis will be done by an appropriate test.
-For subjective parameters, Wilcoxon rank-sum test will be applicable
-For objective parameters Paired t-test will be applicable.
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
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Newly diagnosed patient with Prameha Purvarupa w.r.t prediabetes.
- •i.e. -HbA1c- 5.7-6.4% or -FBS- 100-125 mg/dl or -PPBS- 140-199 mg/dl.
- •Subjects of age group between 20-70yrs (20-70 both inclusive) will be in the inclusive.
- •Both males and females (female- non-lactating and not pregnant) will be in the inclusion.
- •Written consent showing willingness to participate in the study.
- •The patient will be taken according to American Medical Association Criteria for diagnosis of Diabetes Mellitus.
排除标准
- •Age under 20 years and over 70 years.
- •Type-II DM (NIDDM) with and without complications 3)Type-I DM (IDDM) associated with and without complications 4)Known cases of Diabetes due to endocrinopathies, for example, pheochromocytoma, acromegaly, Cushing’s syndrome, etc.
- •Patients having disorders like carcinoma anywhere in the body or any other major life-threatening disease.
- •Known cases of drug or chemical-induced DM, such as glucocorticoids, thyroid hormone, thiazides, phenytoin, etc.
- •Known cases of Certain genetic syndromes sometimes associated with DM, e.g., Down’s syndrome, Klinefelter’s syndrome, Turner’s syndrome, etc.
结局指标
主要结局
Reduction in HbA1C levels from baseline, indicating improvement in glycemic control among prediabetes individuals
时间窗: follow up will be 30 days for 3 months (90 days)
次要结局
- reduction in BMI, indicating weight management improvement as part of lifestyle intervention.(improvement in waist to hip ratio.)
研究者
DR HETALBEN M PATEL
PG STUDANT AT THIS COLLEGE