临床试验/CTRI/2022/02/040297

CTRI/2022/02/040297已完成2 期

Preclinical and clinical evaluation of the effect on oral administration of PARUMA NOI NIVARANA MAATHIRAI & NEERMULLI OORAL KUDINEER along with external therapy PODI THIMIRTHAL in the management of BAALAR ATHITHOOLA ROGAM.

Dr J Mangalavalli1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2022年2月18日最近更新: 2023年1月8日

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 40
试验地点: 1
主要终点: 1.To reduce the excess weight

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study is a single arm clinical trial focussing on preclinical and clinical evaluation of the effect on oral adminiostration of PARUMA NOI NIVARANA MAATHIRAI & NEERMULLI OORAL KUDINEER along with external therapy PODI THIMIRTHAL in the management of BAALAR ATHITHOOLA ROGAM.

If any ADR is encountered , it will be reported to Pharmacovigilance department , SCRU Palayamkottai.

研究设计

研究类型: Interventional
分配方式: Not Applicable
盲法: Not Applicable

入排标准

年龄范围: 5.00 Year(s) 至 12.00 Year(s)（—）
性别: All

入选标准

•1.Inappropriate weight for height 2.Raised BMI 3.Abdominal adiposity 4.Increased skin fold thickness All of these associated with any one of the following : a.Shortness of breath b.Dark and thickened skin especially in the skin folds and creases c.Joint pain d.Trouble sleeping 5.Willing for regular follow-up in OPD 6.Willing to put admission in IPD.

排除标准

•1.Children above 12 years 2.Children below 5 years 3.Cases due to endocrine reasons 4.Hypothalamic obesity 5.Genectic syndromes 6.Monogenic disorders 7.Under the use of antiepileptic drugs,corticosteroids,antipsychotics,antidepressants and oestrogen.

结局指标

主要结局

1.To reduce the excess weight

时间窗: 40 days

2.To maintain weight within normal limits.

时间窗: 40 days

次要结局

未报告次要终点

研究者

发起方

Dr J Mangalavalli

申办方类型

Other [self]

研究点 (1)

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