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临床试验/CTRI/2024/05/067699
CTRI/2024/05/067699尚未招募2 期

Single centric non Randomized open clinical Trial Phase II In Azhal thalainokkadu Sinusitis with Siddha Medicine Peenisa Chooranam among patients attending opd at Government Siddha medical college Hospital Chennai

R Sujatha1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月9日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
The outcome of the treatment will be mainly assessed by reduction in clinical symptoms such as nasal obstruction,rhinitis,Post nasal drip,head ache ,facial pain.

研究概览

简要总结

Sinuses are four paired cavities inside the head. narrow passages connect them. sinuses make mucus that drains out of the passages through nose. this drainage helps keep the nose clean and free of bacteria, allergens and other germs. sinusitis is an inflammation, or swelling, of the tissue lining of sinuses. Sinuses are structures inside the face that are normally filled with air. bacterial infections, viral infections and allergies can irritate them. causing them to get blocked and filled with fluid. it can cause pressure and pain in the face, nasal congestion and other symptoms. symptoms include nasal inflammation, thick discolored discharge from the nose, drainage down the back of the throat, nasal obstruction or congestion, pain, tenderness and swelling around the eyes, cheeks, nose or forehead, reduced sense of smell and taste, ear pain aching in upper jaw and teeth and cough.

Types of sinusitis can be defined based on how long it’s been going on and what’s causing it. acute sinusitis symptoms last less than four weeks. Subacute sinusitis symptoms last from to 12 weeks. chronic sinusitis symptoms last at least for 12 weeks. recurrent acute sinusitis symptoms come back four or more times in one year last less than two weeks each time.

In Siddha system of medicine, there are many unique combinations of medicines which have solution to the scenario of "AZHAL THALAINOKKADU"(SINUSITIS). one such combination is PEENISA CHOORANAM which will be cost effective and reliable.

so, it is considered to evaluate the siddha herbal formulation PEENISA CHOORANAM mentioned in DHANVANDHRI SOOTCHAMA VAITHIYAM 200 VISHA BEDHI VAITHIYAM page no 36 for the treatment of " AZHAL THALAINOKKADU"(SINUSITIS). the therapeutic efficacy of this Siddha formulation is so for not evaluated clinically for this disease.so the author tries to evaluate its efficacy in an open clinical trial.

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 All gender 2 Rhinorrhea 3 Nasal congestion 4 Pain and tenderness over paranasal sinus 5 Headache.

排除标准

  • 1 Septal deviation 2 Fungal sinusitis 3 Opthalmic headache 4 Trigeminal neuralgia 5 Sinus polyposis 6 Migraine 7 Otitis media 8 Vasomotor rhinitis 9 Pregnant and Lactating mother.

结局指标

主要结局

The outcome of the treatment will be mainly assessed by reduction in clinical symptoms such as nasal obstruction,rhinitis,Post nasal drip,head ache ,facial pain.

时间窗: 4weeks

次要结局

  • Reduction in clinical symptoms like nasal obstruction rhinorrhea post nasal drip headache(28 days)

研究者

发起方
R Sujatha
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

R Sujatha

Government Siddha Medical College Chennai

研究点 (1)

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