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临床试验/CTRI/2018/02/011886
CTRI/2018/02/011886已完成3 期

A COMPARITIVE CLINICAL STUDY ON THE EFFECT OF VAMANA KARMA WITH DHAMARGAVA AND VATSAKA BEEJA FOLLOWED BY LEKHANEEYA GHANA VATI IN THE MANAGEMENT OF MEDOROGA W.S.R TO DYSLIPIDEMIA

National Instititute of Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年5月4日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Both groups showed significant improvement and result of intergroup comparision was non significant

研究概览

简要总结

The present clinical study entitled “A comparative clinical study on the effect of Vamana Karma with Dhamargava and Vatsaka Beeja followed by Lekhaneeya Ghana Vati in the management of Medoroga w.s.r to Dyslipidemia†was carried out in 30 patients divided in 2 groups. In both the groups patients were treated with Vamana Karma with two different drugs followed by Shamana Auashadi with the following aims and objectives.

Aims & Objectives:

·               To evaluate the effect of Vamana Karma with Dhamargava Yoga and Lekhaniya ghana vati in the management of  Dyslipidemia.

·               To evaluate the effect of Vamana Karma with Vatsaka Beeja Yoga and Lekhaniya ghana vati in the management of Dyslipidemia.

·               To compare the effect of Vamana Karma with Dhamargava Yoga and Vatsaka Beeja Yoga in the management of Dyslipidemia.

Materials and methods:

Materials:

Clinical study materials: 30 patients.

Source of data: Patients indicated and fit for trial were selected from outpatient and inpatient department of Panchakarma, National Institute of Ayurveda Hospital, Jaipur.

Conceptual study materials: Books, internet, journals.

Drugs used in the trial:

Allthe medicines were procured from National Institute of Ayurveda Pharmacy, Jaipur, except Dhamargava phala which was collected from jalagaon dist. Maharashtra.

Methods:

Research design:

A comparative randomized clinical study.

Statistical method: Student paired and unpaired t test, Wilcoxon test, Manwhitney U test.

Method of collection of data: Patients were thoroughly examined both subjectively and objectively. Detailed history pertaining to previous ailment, previous treatment history, family history, habits, physical examination and systemic examination findings were noted.  Routine investigations were carried out to exclude other systemic pathology. Subjects were registered in the clinical trial and detail information was documented in the case proforma prepared for the study.

Patient   consent: In the respective group, the treatment procedure with its different steps and the outcome is properly explained in detail to the patients, written consent from the patients was obtained before enrolling in the clinical study.

Diagnostic criteria:

1.      Abnormal levels ofserum lipid profile.

2.      Clinical features of Dyslipidemia and Medoroga like Ashaktaha Sarva Karmasu, Kshudra Shvasa, Svedadhikya, Utsahahani, Angagaurava.

Inclusion criteria

·         Aged between 20-60 yrs.

  • Serum lipid levels more than normal ranging from:

S.cholesterol (201mg/dl or more)

S.Triglycerides (161mg/dl or more)

Serum LDL (131mg/dl or more)

Serum VLDL (41mg/dlor more)

·         Having clinical features of Medoroga

·         Fit for Vamana Karma

Exclusion criteria

  • Age below 20 years & above  60 years.

·         Associated with serious illness like Carcinoma Cardiac Failure, Malignant Hypertension.

·         Not fit for Vamana Karma.

Laboratory investigation

Following investigation will be carried out before & after treatment;

·         Routine blood investigation.

·         ECG to rule out Cardiac Pathology.

·         Lipid profile.

·         Routine urine analysis.

Assessment criteria

A) Objective parameters:

Objective criteria were mainly assessed on the basis of biochemical investigations like lipid profile (in selected patients) and also body weight, BMI  and waist hip ratio, before starting the treatment and after completion of treatment  were assessed in terms of percentage relief and statistical evaluations.

1. Lipid profile: Complete profile including serum cholesterol, serum triglycerides, serum HDL, serum LDL, serum VLDL were assessed

2. Body weight**:** It was assessed by using weighing machine in kilograms

3. Body mass index (BMI)****: The body mass index (BMI) or Quetelet index is a statistical measurement which compares a person’s weight and height. The frequent use of the BMI is to assess how much an individual’s body weight departs from what is normal or desirable for a person of his or her height.

India has reworked the obesity guidelines by considering the alarming growth of abdominal obesity by lowering the BMI from 25 kg/m2 for overweight to 23 kg/m2.

(http://www.igovernment.in/site/India-reworks-obesity-guidelines-BMIlowered/ accessed on 04/24/12)

4. Waist-Hip ratio: It is the ratio of the circumference of the waist to that of the hips. According to the world health organisation data gathering protocol, the waist circumference should be measured at the mid point between the lower margin of the last palpable rib and the top of the iliac crest, using a stretch –resistant tape  that provides a constant 100g tension. Hip circumference should be measured around the widest portion of the buttocks, with the tape parallel to the floor. WHO STEPS states that abdominal obesity is defined as a waist-hip ratio above 0.90 for males and 0.85 for females.

B) Subjective parameters:

Signs and symptoms of Medoroga were used for symptomatic evaluation for which a multidimensional scoring pattern was adopted. The patients were assessed  by giving a score before and after Vamana Karma and after Shamana Aushadi  according to the severity of the symptoms.

The below following four parameters were assessed.

1. Sarva Karmasu Ashaktata

2. Kshudra Shvasa

3. Svedadhikya

4. Dourbalya

Overall effect of the treatment:

In Group A (Vamana Karma with Dhamargava) out of 15 patients, 39.96% patients had mild improvement, 13.32% patients had moderate improvement, 6.66% patients showed good improvement while 39.96% patients had no improvement after Vamana. After overall treatment 39.96% patients showed mild improvement, 6.66% patients had moderate improvement and 53.28% patient had no improvement.

In Group B (Vamana Karma with Kutaja) among 15 patients, 46.62% patients showed mild improvement, 6.66% each had moderate and good improvement. 39.96% patients had no improvement after Vamana. And after complete treatment 53.28% had mild improvement 6.66% had moderate improvement and 39.96% had no improvement.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1 Serum lipid levels more than normal ranging from: S.cholesterol (201 mg/dl or more) S.Triglycerides (161 mg/dl or more) Serum LDL (131mg/dl or more) Serum VLDL (41mg/dl or more) 2 Having clinical features of Medoroga 3 Fit for Vamana Karma.

排除标准

  • 1 Age below 20 years & above 60 years.
  • 2 Associated with serious illness like Carcinoma Cardiac Failure, Malignant Hypertension.
  • 3 Not fit for Vamana Karma.

结局指标

主要结局

Both groups showed significant improvement and result of intergroup comparision was non significant

时间窗: 9 months

次要结局

  • on an average weight reduction upto 5 kg(wt reduction was observed within 2 months of trial duration)

研究者

发起方
National Instititute of Ayurveda
申办方类型
Government medical college

研究点 (1)

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