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临床试验/CTRI/2025/09/094651
CTRI/2025/09/094651尚未招募2 期

Efficacy of Zulaal-e-Tamarhindi orally along with Arad Jau and Sirka vs Roghan Gul and Sirka topically in Shara (Urticaria)- A Comparative Clinical Trial.

Government Unani Medical College and hospital1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年11月15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
34
试验地点
1
主要终点
1.Decrease in CRP and ESR levels.

研究概览

简要总结

***Shara (***Urticaria) is a vascular reaction of the skin characterized by the appearance of wheals, generally surrounded by red flare and associated with severe itching, stinging or pricking sensation. The term Urticaria is derived from Latin word urtica and urere, which means nettle and to burn It is commonly called as hives. Urticaria which lasts for more than 6 to 8 weeks duration is called Chronic Urticaria (CU). CU is a common dermatological condition affecting an estimated 15 to 20percent of the general population at least once during lifetime. Females are nearly twice as frequently affected as males and the peak incidence of chronic Urticaria falls between 20-40years of age. The global age standardized prevalence incidence and DALY (Daily Adjusted Life year) rates of Urticaria showed marginal changes In 2019 65.14 million individuals were affected with a prevalence rate of 841.88per 100000 population.The DALY rate was 50.39 per 100 000 population. Nationally,Urticaria prevelance in 2019 varied dramatically, from a low of 27.1 per 100000 population in Portugal to a high of 92.0 per 100000 population in Nepal India reported most DALYS at 749495.9followed by China, Pakistan and United states.

Clinical features of Shara are recurrent skin eruptions heat and pricking sensation followed by appearance of lesions. It is also characterized by edematous wheals surrounded by red flare intense itching with burning sensation which usually increases in the evening.

In conventional medicine Antihistamines of theH1 receptor blocker such as Promethazine, Diphenhydramine, Fexofenadine, Astemizole,  Cetrizine, Loratidine are effective and H2 antagonist such as Cimetidine and intravenous hydrocortisone  are available for the management of Chronic Urticaria.But these drugs exert adverse effect like hepatotoxicity, cardiotoxicity, sedative effects anticholinergic effects etc.. There is a need for Alternative system of medicine in the treatment of Shara  as it may have comparatively less side effects and has more potent effects.

According to Unani concept the cause of Shara is Fasad e dam ( impairment of blood)- caused by the vapors of Dam e mirari( bilious blood) or Balgham e Boraqi (acidic phlegm) coming towards the skin or periphery of the body. Principles of treatment of Shara includes removal of the underlying cause use of Musaffi e dam advias (Blood purifiers) and antiallergic drugs.

The Unani physicians recommended both single and compound formulations for the management of Urticaria. Single drugs like Doob, Jau ,Tabasheer, Tamarhindi, Aloo Bukhara, Sirka, kafoor, Rose, Ajwain, Geru, Isapgol,  etc ...Compound drugs like Roghan e gul,  Arq e gulab, Qurs e tabasheer, *sikanjabeen,  Joshanda e halela, Qurs e kafoor, Ma ul jubn,*etc.. These drugs possess properties like  Musakkin e meda,Musakkin *e hararath  (*Soothing agent )Mudir e Baul( diuretic)  *Jali (*detergent) Muhalllil (Resolvant) Qabis (Astringent )Mujaffif  (Desiccant)However, these drugs have not been scientifically explored so far. Hence, Zulaal Tamarhindi orally, along with Arad Jau Barley powder and Sirka Vinegar vs Roghan gul (Rose oil) with Sirka  (vinegar) topically is designed to provide safe, more effective and economical treatment for Shara( Urticaria).

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
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients of all gender between the age group 18 to 50 years.
  • Clinically diagnosed cases of mild less than 20 wheals to moderate (20 to 50 wheals) Chronic Urticaria, Patients who are willing to sign the consent form for the trial.

排除标准

  • Uncontrolled DM RBS greater than 200mg per dl Hypertension Renal impairment skin infections and any malignancy Immunocompromised patients, History of treatment for Chronic Urticaria in past 1 month, Patients suffering from skin infections other pigmentary and inflammatory skin diseases Pregnant and lactating women.

结局指标

主要结局

1.Decrease in CRP and ESR levels.

时间窗: 1.Decrease in CRP and ESR levels on 0th and 28th day. | 2.Changes in UAS7 Score on 7th 14th 21st 28th day.

2.Changes in UAS7 Score.

时间窗: 1.Decrease in CRP and ESR levels on 0th and 28th day. | 2.Changes in UAS7 Score on 7th 14th 21st 28th day.

次要结局

  • 1 Improvement in Subjective parameters(2 Reduction in CUQ2OL Score)

研究者

发起方
Government Unani Medical College and hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Rumana Shabnum

Government Unani Medical College and Hospital

研究点 (1)

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