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临床试验/CTRI/2024/06/068986
CTRI/2024/06/068986尚未招募不适用

An observational study to compare the efficacy of hijamah bis shurt (wet cupping) and Bed sada (Salix Alba) in the management of tassamum fid dam (hyperlipidaemia)

Islamic University of Science and technology1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Lipid Profile (Triglycerides and LDL)

研究概览

简要总结

Hyperlipidaemia/Dyslipidaemia (Fart e Tassamum fid dam) is a major health problem as it plays an important role in the development of coronary artery disease (CAD) and is responsible for more than four million deaths annually and also accountable for developing IHD worldwide. In Asia, the prevalence of coronary heart disease (CHD) is approximately four times higher as compared to the general population in the USA. If it is not monitored properly or left untreated, it affects overall health and could lead to catastrophic consequences like atherosclerosis, stroke, and ischemic heart disease (IHD). Studies have proved well well-established association between dyslipidemia and the development of cardiovascular diseases. In the Unani system, it is described elaborately about the ill effects of management, if fat is pathologically increased in blood. When these oily substances of blood reach different organs of the body, they start to deposit there in the form of fat (Shahm) due to BaridMizaj (Cold temperament) of those organs.Siman-eMufrit (obesity)has also been discussed extensively and managed in the Unani system of medicine (USM) for centuries. The possible consequences of obesity are Khafqan (palpitation),Salabat-e-Nabz (Atherosclerosis), Sakta (Stroke), Zeeq-un-Nafas(breathlessness), Coma, and sudden death are very much similar to the signs, symptoms and complications of dyslipidemia defined in conventional medicine. Hence, Siman-e-Mufrit is a disease in which there is a deposition of BaridRatabMad’da(Shahm/Lipid) and it falls under the category of Amraz-e-Balghamiya.In Unani classical literature Barg-e-Bed Sada has some actions, like Muqawwi-e-Dimag (Brain Tonic), Muqawwi-e-Qalb (Cardiac Tonic), Zof-e-Meda (Cardiac Asthenia), Mudir-e-Baul (Diuretic), Qabiz (Astringent). So, it is used to cure many diseases such as Tape-Haar (Acute Fever), Ramad (Acute Conjectivitis), Sara (Epilepsy), Yarqaan (Jaundic), Warm-e-Tihal (Hepatomegelly), Khafqaan (Palpitation), Jadri (Chickenpox), Ikhtinaq-i-Reham (Hysteria), Waja-ul-Mafasil (Arthritis), Niqras. Hijamah is also used for the treatment of Hyperlipidaemia. The present study was designed to compare the efficacy of regimenal therapy and pharmacotherapy and determine which was more efficacious

Study design: Open, comparative study.

 Sample size: 30 patients; 15 in each group.

 Intervention. Hijamah bis Shurt

Number of Cups: 2 cups on interscapular area.

 Test Drug: Salix Alba

 **Part used:**Bark

 Dosage: 7 grams

 **Method of Prepration:**Boil 7 grams of dried and powdered bark of Salix Alba in 35ml of water and strain, then taken in the morning after breakfast.

Duration and Procedure of Intervention:

The area will be selected and cleaned thoroughly with betadine, then two cups will be taken and suction will be applied with the help of a suction machine for five minutes after which cuts will be made with sterile 11 no surgical blade and the cups are applied again and suction applied again and blood is taken out till another five minutes, then the cups will be removed and will be disposed properly, the wound will be cleaned again and surgical dressing will be applied. This procedure will be done every 15 days for two months.

Duration of Study: 2 years

Procedure of study:

Enrolled cases of dyslipidaemia will be randomly allocated into two groups of 15 each, after obtaining a written informed consent. Group A will be allocated forHijamahbisShurt(Wet cupping)  and Group B will be treated with Salix Alba.

The pre and post treatment subjective and objective findings (effects) will be compared in both groups, and its significance will be evaluated through a suitable statistical test.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • 1.Patients of either sex will be selected for the study.
  • 2.Between 18 to 60 years of age.
  • 3.Patients with deranged blood lipid profile levels.

排除标准

  • 1.Patients below 18 and above 60 years of age.
  • 2.Pregnant and Lactating mothers.
  • 3.Patients who fail to give consent.
  • 4.Patients with history of severe illness, Cardiovascular diseases, Renal, Liver diseases.
  • 5.Anaemic patients, Patients on blood thinners, Patients with history of bleeding disorders.

结局指标

主要结局

Lipid Profile (Triglycerides and LDL)

时间窗: Baseline and after 8 weeks

次要结局

  • 1. Breathlessness(2. Fatigue)

研究者

发起方
Islamic University of Science and technology
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Tabasum Fatima

Islamic University of Science and Technology

研究点 (1)

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