临床试验/CTRI/2025/02/080754

CTRI/2025/02/080754招募中2/3 期

Randomized Controlled Trial of Efficacy of Mustadi Ghanvati With and Without Udvartana in Medoroga With Special Reference to Hyperlipidemia on Lipid Profile

Government Ayurveda College and Hospital, Nagpur1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2025年3月1日最近更新: 2025年2月10日

试验速览

阶段: 2/3 期
状态: 招募中
发起方
入组人数: 60
试验地点: 1
主要终点: To evaluate the efficacy of Mustadi Ghanvati with and without Udvartana in

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Plan of work

After Institutional Ethics Clearance of Government Ayurved College, Nagpur Screening of Population will be done from Patients in OPD, IPD of our hospital attached to institute. In the Clinical study 60 Patients of Medoroga with Hyperlipidemia will include. Assessment of lipid profile and clinical symptoms of Medoroga will be done. If patient fulfill the criteria of inclusion, subject would also give freedom to ask the questions and all questions would answer. If he/she agrees for participation in the study and found fit to include then that patient will be included in a study.

The treatment will be given to patient as follows:

Group A (Trial Group)

0 Day assessment (Before treatment) on recruitment day

2) Udvartana with Mustadi Churna At morning before bath for 20 mins daily (for 15 days)+ Mustadi Ghanvati 500 mg 2 TID (3 g/day) With Lukewarm water Before meal (for 15 days)

Mid treatment assessment (on 16th day) Udvartana with Mustadi Churna At morning before bath for 20 mins daily (for next 15 days)+ Mustadi Ghanvati 500 mg 2 TID (3 g/day) With Lukewarm water Before meal For next 15 days
Assessment after completion of treatment (On 31st day)

Group B(Control Group)

1)0 Day assessment (Before treatment) on recruitment day

2)Mustadi Ghanvati 500 mg 2 TID (3 g/day) With Lukewarm water Before meal (for 15 days)

3)Mid treatment assessment (on 16th day)

4)Mustadi Ghanvati 500 mg 2 TID (3 g/day) With Lukewarm water Before meal (For next 15 days)

5)Assessment after completion of treatment (On 31st day)

Medium of Dissertation: The dissertation will be written in English by using Ayurvedic terminology where ever necessary in Sanskrit.

Study Setting: OPD and IPD of hospital attached to institute.

Study Design: Randomized Controlled Trial

Duration of study: 18 months

Duration of Treatment: 30 days

Ethical Clearance: Clearance from Institutional Ethics committee of our Institute

Study Population:

All obese patients attending OPD, IPD of our institute will be considered in this study.

Patients in between age group of 20 – 70 years.

Patient will be diagnosed on the basis of lipid profile and symptoms of Medoroga according to Ayurvedic Classics.

Sample Size:

Sample size was calculated with the help of data published by Nadkarni MA, Vyas SN, Baghel MS, Ravishankar B. Randomized placebo-controlled trial of Mustadi Ghanavati in hyperlipidaemia.

Required Sample Size per group is 26

Considering 10% dropout/non-response, Hence Final Sample Size in each group is 30.

Physical characters will be assessed on the basis of following Questionnaires and Scales:

A) OBJECTIVE CRITERIA:

1] ANTHROPOMETRIC CHARACTERS

1.Height

2.Weight

3.BMI

4.Abdominal circumference

5.Waist circumference

6.Hip circumference

7.Waist Hip Ratio

8.Skinfold Thickness - a. Abdominal b. Bicep c. Triceps

2] CLINICAL PARAMETERS:

1.SPO2

2.Pulse Rate

3.Respiration Rate

4.Blood Pressure

Temperature

3] BIOCHEMICAL PARAMETERS:

Lipid profile
Blood sugar level fasting and Post Prandial
Complete blood count
Erythrocytes sedimentation rate
Urine routine and microscopic

B) OBJECTIVE CRITERIA:

1] Symptoms of Medoroga

2] Lipid Profile

3] BMI

4] Waist hip ratio, abdominal circumference and skin folds (abdominal, biceps & triceps)

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

•Patients who are willing to participate in trial and ready to give written consent.Patient having minimum fifty percent symptoms of medoroga according to classics and fulfilling diagnostic criteria of this study.Male and females, aged between twenty to seventy years irrespective of caste religion socioeconomic and educational status.Patient whose lipid profile shows any one or both of the following diagnostic criteria of hyperlipidemia that is serum cholesterol 201 mg per dl upto 1000 mg per dl, Serum Triglycerides 151 mg per dl upto 1000 mg per dl will be selected.Patients of Medoroga having BMI more than 25 Kg per m2 and less than 40 Kg per m2.Patient with controlled HTN BP Systolic less than 150 and Diastolic less than 100 mmHg and DM having FBS less than 150 mg per dl and PMBS less than 250 mg per dl.Patient who had not participated in any research work since last six months will be included.

排除标准

•Patients who are not willing to participate in trial and not ready to give written consent.
•Patients having age below 20 years and above 70 years.Patients who have uncontrolled HTN BP Systolic greater than 150 and Diastolic greater than 100 mmHg. Patients who have uncontrolled DM FBS greater than 150 mg per dl and PMBS greater than 250 mg per dl.Patients having history of serious cardiac disorders like myocardial infarction cardiac failure etc.
•and any other serious renal hepatic respiratory diseases etc.
•will also be excluded.Patients having a history of untreated thyroid disorders.Patients who are unfit for udvartana like skin disorders injury or wound hypersensitive.Drug induced hyperlipidemia like glucocorticoids induced hyperlipidemia.Pregnant females and lactating mothers.Who are currently participating in any other clinical trial from last 6 month.