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Paneer Fool

Exploring the Therapeutic Potential of Withania coagulans Extract in Prediabetes Management: A Randomized Controlled Trial

Introduction

  1. Diabetes mellitus represents a global health crisis, with alarming growth in India
  2. Current pharmaceutical interventions have incomplete metabolic regulation, necessitating the exploration of complementary approaches
  3. Withania coagulans (family Solanaceae), commonly known as “Paneer ke phool” in Hindi and “Indian cheese maker” in English, is a medicinal plant distributed throughout the drier regions of India.
  4. This plant has attracted significant scientific interest due to its reported anti-diabetic, anti-inflammatory, cardioprotective, and hepatoprotective properties.
  5. Multiple studies have demonstrated the anti-hyperglycemic potential of Withania coagulans.
    1. The methanolic fruit extract has been shown to improve glucose absorption in yeast cells by up to 90% at various glucose concentrations, with the highest concentration (5 mg/ml) showing an 81.83% increase in glucose uptake
    2. Withanolides, the bioactive compounds in Withania coagulans, are believed to be responsible for this anti-hyperglycemic activity through enhanced glucose transport across cell membranes

Primary Objective

To evaluate the efficacy and safety of Withania coagulans extract as a complementary intervention in the management of type 2 diabetes and prediabetes.

Specific Aims

  1. To assess the impact of Withania coagulans extract on glycemic control in type 2 diabetic patients when added to standard medical care
  2. To evaluate whether Withania coagulans extract can prevent or delay progression from prediabetes to type 2 diabetes
  3. To investigate the effects of Withania coagulans extract on insulin sensitivity, and β-cell function
  4. To assess the safety and tolerability of Withania coagulans extract in both diabetic and prediabetic populations

Methodology

Study setting

B. K. L. Walawalkar Hospital and nearby community / villages

Study Population

  1. Subjects having Type 2 DM according to inclusion criteria.
  2. Subjects who are screened as part of the Madhusagar project, or diabetic/prediabetic patients who come to the OPD will be the provided a background of the study, its objectives and methodology.
  3. Based on their consensus and consent to be included in the study, they will be randomized and included in one of the four arms.
  4. Inclusion and exclusion criteria is detailed in the next column below.

Inclusion Criteria

Type 2 Diabetes Arms (1 & 2)
  1. Age 30-65 years
  2. Diagnosed with type 2 diabetes for at least 6 months
  3. HbA1c between 7.0% and 9.5%
  4. On oral antidiabetic medications for at least 3 months
Prediabetes Arms (3 & 4)
  1. Age 30-65 years
  2. Fasting plasma glucose 100-125 mg/dL or HbA1c 5.7-6.4%

Exclusion Criteria

  1. Type 1 diabetes
  2. Use of insulin therapy
  3. Significant renal impairment
  4. Significant hepatic dysfunction
  5. History of cardiovascular events within last 6 months
  6. Pregnancy or breastfeeding
  7. Participation in another clinical trial within the past 3 months

Preparation of Withania coagulans Extract for Intervention (Arm2 and Arm 4)

  1. The ethanolic extract of Withania coagulans fruits will be prepared following standardized procedures.
  2. The extract will be standardized for withanolide content using HPLC to ensure consistent potency.
  3. Based on previous studies, the extract will be formulated into capsules containing a dose equivalent to 500 mg, which has been identified as effective dose in preclinical studies.

Preparation of Placebo (Arm1 and Arm 2)

  1. Placebo will be identical-looking capsules, prepared with same excipients without adding the ethanolic extract of Withania coagulans

Outcome Measures

Primary Outcomes
  1. Change in HbA1c from baseline to 12 weeks
  2. Reduction in number of prediabetic individuals progressing to type 2 diabetes during the study period
Secondary Outcomes
  1. Changes in medication requirements for type 2 diabetic patients
  2. Changes in fasting plasma glucose and postprandial glucose
  3. Changes in insulin sensitivity (HOMA-IR)
  4. Changes in β-cell function (HOMA-β)
  5. Samples collection for DNA studies in future.

IEC Approval

IEC Approval

Institutional Ethics Committee approval for Planetary positions favorable for medical professionals

Preview Document

Information

Methodology

Distribute a questionnaire to collect data

  1. On Horoscope Sign(moon sign)
  2. Informed consent of student
  3. Astrology & Horoscope app

Sample size – 150

Horoscope of 150 medical students.

Data analysis

  1. Analysis of Zodiac SIGNS
  2. Analysis of lagna Nakashatra
  3. Study of 10th & 5th primary houses
  4. 2nd , 9th & 11th as secondary houses
  5. Placement of Sun, Mars, Saturn, Jupiter ,Venus in horoscope.

Research Question

Is there a correlation between horoscope signs and career choice as medical profession among medical student?

Inclusion criteria

Horoscope of 150 students of MBBS course.

Exclusion criteria

Horoscope of Student from field other than Medical course

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