Clinical Assessment of antisickling herbomineral formulation T-AYU-HM Premium on sickle cell anemia at Dhanvantari clinic OPD patients: A prospective study - SCA-AHP-F

Dhanvantari Clinic Ayurveda Health Care and Research Center0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年5月27日

试验速览

暂无简介。

•1.Patients between the ages above 07 to 55 years from both sexes from sickle hemoglobin.
•2.Written informed parental/guardian consent and participant assent (where applicable) has been obtained per requirements, consistent with ICH guidelines.
•3.Participant/Guardians must agree to adhere to Treatment guidelines.
•4.Willingness to sign an informed written consent and comply with visit schedules.
•5.Participants confirms of HBSS through HPLC
•6. Participant who are confirmed Sickle cell anemia patients with positive microscopic sickle cell test, sickle cell solubility test.
•7.Participants exhibit no other existing comorbidities
•8.Participants having Negative Hepatitis B test.
•9.Hemoglobin = 6.0 and = 11.0 g/dL during screening
•10.Participants/Guardians agree to provide regular feedback and questionnaire during schedule visit
•11. Participants having veg/non veg diet
•12.Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment
•13.Participant needs to be admitted to the ambulatory site for treatment of VOC requiring pain medication

•1.Participants not willing to participate
•2.Participants having renal impairment
•3.Participants not willing to visit clinic for schedule follow up.
•4.Any other condition which the Principle Investigator thinks may jeopardize the study
•5.Pregnant / lactating woman
•6.Participants with unresolved infections or existing comorbidities.
•7.Participants on any other treatment within 07 days of the first dose of study drug or who have not recovered from the side effects of such therapy
•8.Participants have history of hospitalized treatment or blood transfusion before 15 days.
•9.Participants taking any other then investigational drug in last 7 days
•10.Participants who are allergic/Hypersensitivity reactions to herbal supplements and medications.
•11.Participants who are unable to take and absorb oral medications, unable to swallow tablets.
•12.Participants who are not able to understand and to comply with study instructions and requirements.

发起方

Dhanvantari Clinic Ayurveda Health Care and Research Center