Background:Shara,commonly known as Urticaria,is a common skin dermatological disorder characterized by the sudden onset of erythematous itchy wheals.It affects approximately 20%of the population at some point in their...Background:Shara,commonly known as Urticaria,is a common skin dermatological disorder characterized by the sudden onset of erythematous itchy wheals.It affects approximately 20%of the population at some point in their lives.It can significantly impair the quality of life of chronic sufferers due to the lack of a permanent cure.Objective:Given the historical efficacy of Unani traditional medicine in addressing chronic diseases,this study aims to evaluate the effectiveness of Unani pharmacopoeial preparation in managing urticaria by conducting a standard controlled clinical trial.Methods:A Randomized single blinded Controlled Clinical trial was carried out on 60 diagnosed patients of Shara at Ajmal Khan Tibbiya College Hospital,AMU,Aligarh,India between 2022 and 2023.Patients were allocated into two groups through computer generated randomisation.Patients in standard group were given levocetirizine 5 mg daily while patients of test group were subjected to Nuqu-e-Unnab(c onsisting of Zizyphus jujuba,Prunus domestica,Coriandrum sativum,Fumaria officinalis)7 g with Sikanjabeen-e-sada(made from honey and vinegar)18 mL BD for six weeks.Patients were assessed on day 0,day 14 day,day 28 and day 42.Blood samples were taken before and after the treatment.Urticaria Activity Severity Index(UAS7),dermatology life quality index(DLQI)scores along with common clinical features were assessed to obtain the clinical efficacy of the test drug.After completion of the trial,comparison was made between pre-and post-treatment values and symptoms.Result:Thirty patients in each group were analysed.A significant reduction was seen in UAS7 Score in both the standard and test groups from 22.97±1.25 to 10.13±1.15(P<0.001,55.9%)and 24.9±1.25 to 11.33±1.49(P<0.001,54.5%)respectively.Whereas,DLQI score was also reduced from 16.97±0.98 to 8±0.85 and 16.13±0.92 to 7.9±1.09 respectively.Patients in standard group exhibited headache(4 patients),sedation(6 patients)and drowsiness(12 patients)whereas in test group,patients complained of headache(2 patients),throat irritation(4 patients)and burning stomach(4 patients).Conclusion:The test drug appeared to be as effective as levocetirizine and was found safer than levocetirizine as the incidence of adverse effects was seen higher with levocetirizine as compared to the test drug.The study protocol was approved by Institutional Ethics Committee(IEC),Ajmal Khan Tibbiya College,Aligarh Muslim Uni-versity,Aligarh at its meeting on April 02,2022(registration number 776/FUM dated 23/04/2022).The trial was started after registration on clinical trial registry-India(CTRI)with registration number CTRI/2022/10/046562.展开更多
基金support by Aligarh Muslim University,Aligarh,India。
文摘Background:Shara,commonly known as Urticaria,is a common skin dermatological disorder characterized by the sudden onset of erythematous itchy wheals.It affects approximately 20%of the population at some point in their lives.It can significantly impair the quality of life of chronic sufferers due to the lack of a permanent cure.Objective:Given the historical efficacy of Unani traditional medicine in addressing chronic diseases,this study aims to evaluate the effectiveness of Unani pharmacopoeial preparation in managing urticaria by conducting a standard controlled clinical trial.Methods:A Randomized single blinded Controlled Clinical trial was carried out on 60 diagnosed patients of Shara at Ajmal Khan Tibbiya College Hospital,AMU,Aligarh,India between 2022 and 2023.Patients were allocated into two groups through computer generated randomisation.Patients in standard group were given levocetirizine 5 mg daily while patients of test group were subjected to Nuqu-e-Unnab(c onsisting of Zizyphus jujuba,Prunus domestica,Coriandrum sativum,Fumaria officinalis)7 g with Sikanjabeen-e-sada(made from honey and vinegar)18 mL BD for six weeks.Patients were assessed on day 0,day 14 day,day 28 and day 42.Blood samples were taken before and after the treatment.Urticaria Activity Severity Index(UAS7),dermatology life quality index(DLQI)scores along with common clinical features were assessed to obtain the clinical efficacy of the test drug.After completion of the trial,comparison was made between pre-and post-treatment values and symptoms.Result:Thirty patients in each group were analysed.A significant reduction was seen in UAS7 Score in both the standard and test groups from 22.97±1.25 to 10.13±1.15(P<0.001,55.9%)and 24.9±1.25 to 11.33±1.49(P<0.001,54.5%)respectively.Whereas,DLQI score was also reduced from 16.97±0.98 to 8±0.85 and 16.13±0.92 to 7.9±1.09 respectively.Patients in standard group exhibited headache(4 patients),sedation(6 patients)and drowsiness(12 patients)whereas in test group,patients complained of headache(2 patients),throat irritation(4 patients)and burning stomach(4 patients).Conclusion:The test drug appeared to be as effective as levocetirizine and was found safer than levocetirizine as the incidence of adverse effects was seen higher with levocetirizine as compared to the test drug.The study protocol was approved by Institutional Ethics Committee(IEC),Ajmal Khan Tibbiya College,Aligarh Muslim Uni-versity,Aligarh at its meeting on April 02,2022(registration number 776/FUM dated 23/04/2022).The trial was started after registration on clinical trial registry-India(CTRI)with registration number CTRI/2022/10/046562.
