Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Anti-Infective Agents

Dermatologic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Herbal and Botanical

Salicylic Acid

Petrolatum

Salicylates

Clotrimazole

Miconazole

Antifungal Agents

Keratolytic Agents

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Emollients

Neem

Leaf extract of A. indica plus salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks

Salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks

Leaf extract of A. indica plus 6% salicylic acid will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.

Leaf extract of A. indica

Salicylic acid (6%) will be applied on palmer keratotic lesion once daily on bedtime for 12 weeks.

Salicylic Acid (6%)

Petroleum jelly will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.

Petroleum jelly

Mir Misbahuddin, MBBS, PhD

Effects of leaf extract of Azadirachta indica in palmer arsenical keratosis: Randomized, double-blind, placebo-control trial

The objective of this study is to evaluate the effectiveness of topical administration of the Leaf of Azadirachta indica in the treatment of palmer arsenical keratosis. Fifty patients of moderate palmer arsenical keratosis patients from an arsenic affected area will be recruited on the basis of inclusion and exclusion criteria and had been drinking arsenic contaminated water for more than six months. They will be divided into two groups each will consist of twenty five members. One group will be provided A. indica plus 6% salicylic acid ointment to apply on palm overnight daily for 12 weeks. Another group will be provided 6% salicylic acid ointment . Water and nail sample will be collected before starting recruitment to confirm diagnosis. Then again nail sample will be collected before and after the study to see the level of arsenic in skin. Effects will be observed after every two weeks and change will be detected as nil, mild reduction, moderate reduction and fully cured.

Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis

Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis: Randomized, Double Blind, Placebo-controlled Trial

Size and number of keratotic lesions will be reduced. These will be expressed in score.

Arsenic level in nail of the patient will be decrease. Total arsenic level will be estimated by atomic fluorescence spectrometer.

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Prof. and Chairman

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Patients receive oral Azadirachta indica once daily on days 1-28. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis

western blotting

gene expression analysis

pharmacological study

flow cytometry

fluorescence in situ hybridization

azadirachta indica

reverse transcriptase-polymerase chain reaction

Asher Chanan-Khan

RATIONALE: Azadirachta indica may be an effective treatment for chronic lymphocytic leukemia. PURPOSE: This phase I trial is studying the side effects and best dose of Azadirachta indica in treating patients with chronic lymphocytic leukemia.

PRIMARY OBJECTIVES: I. To determine the lowest dose of neem leaf extract (NLE) with antileukemic effect and acceptable toxicity in patients with chronic lymphocytic leukemia (CLL). II. Establish the safety and toxicity of NLE in patients with CLL. SECONDARY OBJECTIVES: I. Determine the efficacy of NLE in patients with CLL defined as overall clinical response (CR + PR) by the IWCLL criterion. II. To develop a pharmacokinetic/pharmacodynamic model relating neem leaf extract exposure to toxicity and pharmacodynamic endpoints in CLL patients that will allow personalized dosing to target optimal drug exposure. III. To conduct correlative studies. OUTLINE: This is a dose-escalation study. Patients receive oral Azadirachta indica once daily on days 1-28. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year.

Azadirachta Indica in Treating Patients With Chronic Lymphocytic Leukemia

Phase I Clinical Trial of Neem Leaf Extract for the Treatment of Chronic Lymphocytic Leukemia

Roswell Park Cancer Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis	NCT01731756	Arsenical Kerat...	Leaf extract of... Salicylic Acid ... Petroleum jelly	18 Years - 60 Years	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Azadirachta Indica in Treating Patients With Chronic Lymphocytic Leukemia	NCT01251250	Refractory Chro... Stage II Chroni... Stage III Chron... Stage IV Chroni...	laboratory biom... western blottin... gene expression... pharmacological... flow cytometry fluorescence in... azadirachta ind... reverse transcr...	18 Years -	Roswell Park Cancer Institute

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