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临床试验/CTRI/2025/03/082902
CTRI/2025/03/082902尚未招募1 期

A COMPARATIVE STUDY ON THE EFFICACY OF SUNDIBALADWAYA KASHAYA WITH NISHA AMALAKI CHOORNA AND SUNDIBALADWAYAKASHAYA WITH KSHEERABALA TAILA 7 AVARTHI IN THE MANAGEMENT OF DIABETIC PERIPHERAL NEUROPATHY: A RANDOMIZED CONTROL TRIAL

Vaidyaratnam Ayurveda College Ollur1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年3月30日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
44
试验地点
1
主要终点
1.Diabetic peripheral Neuropathy analyser:Vibrotherm

研究概览

简要总结

Diabetic Peripheral Neuropathy is the most common complication of Diabetes mellitus. The symptomatology corresponding to the clinical presentation of Diabetic peripheral neuropathy is scattered in Purvarupa (premonitory symptoms)  Lakshana (symptoms) and Upadrava (complications) of Prameha. It can be compared under the broad head of Prameha janya upadrava as it manifests secondary to Diabetes mellitus. It can be treated in dual line of treatment directed at the main disease Prameha and its complications. It will have the same Nidaana, Dosha, and Dushyas as that of the main Disease, though they have Samprapti of its own. When main Disease is managed well complications will disappear.

This study focuses on the combined effect of premeha chikitsa and its upadrava chikitsa together in the management of diabetic peripheral neuropathy. Treating the main disease is very much important in the management of a complication. So, a comparative study of Sundibaladwaya kashaya with Nisha amalaki Choornam and Sundibaladwaya kashaya with Ksheerabala taila 7 avarthi is planned. The participants are selected randomly and given this combination of medicines in an alternate basis and the effect is analysed by neuropathy analyser Vibrotherm and Toronto Clinical Neuropathy Score (TCNS)

研究设计

研究类型
Interventional
分配方式
Other
盲法
Not Applicable

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Diabetic peripheral Neuropathy diagnosed by diabetic peripheral neuropathy analyzer: Vibrotherm
  • Toronto Clinical Neuropathy Score (TCNS) TCNS Score equal or more than 6
  • HbA1c: between 6.5 to 8.5.

排除标准

  • 1.Diagnosed cases of cervical, thoracic and lumbar radicular neuropathy 2.Participants with type 2 DM who are under insulin medication 3.Participants with foot ulcer, amputation 4.Participants who have undergone any clinical trial during past six months.

结局指标

主要结局

1.Diabetic peripheral Neuropathy analyser:Vibrotherm

时间窗: 0TH 30TH 60TH AND 91TH DAY

次要结局

  • 1. Toronto Clinical Neuropathy Score (TCNS)(2. HbA1c)

研究者

发起方
Vaidyaratnam Ayurveda College Ollur
申办方类型
Other [Aided College]

研究点 (1)

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