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临床试验/CTRI/2024/05/066718
CTRI/2024/05/066718招募中2/3 期

Effectiveness of Lākṣādi cūrna Utsādana in comparison with Udgharsana with Triphala cūrna and Dhānyamla in the management of Diabetic Distal Symmetric Polyneuropathy – A Pragmatic Randomized Controlled Clinical Trial

VPSV Ayurveda College Kottakkal1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年5月20日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
38
试验地点
1
主要终点
1. Neuropathy Total Symptom Score 6

研究概览

简要总结

Polyneuropathy is a common and debilitating complication of Diabetes Mellitus, affecting more than half of all Diabetic patients. Currently available drugs are often ineffective and complicated by adverse events, hence treatments not entirely satisfactory. Considerable number of patients are seeking nonpharmacologic/alternative medical systems for their management19. DSPN is one of the most important research area in Ayurveda. Several panchakarma procedures have been studied and results are encouraging.A review of researches of external procedures in complications of prameha like DSPN shows that most of the studies focussed are on efficacy of rooksha procedures udvartana, assuming role of kapha in the pathology of prameha. There are studies showing the effect of udgharsana with Triphala cūrna, Triphala cūrnaand dhānyamla, Triphala cūrnaand taila in prameha or sthoulya. But textual references consider predominance of vata in DSPN. In addition to that extreme apatarpana is contraindicated in prameha by all acharya and which can give raise to mutra graha, ruja, gulma, kshaya etc24. Hence many authors consider snigdha mediated procedures. In uts**ādana, even though the medium is snigdha the mechanism of procedure is same as that of udvartana, rubbing in the upward direction. Thus it can be considered as an administration of snigdha in a controlled manner which will be more useful in complications of prameha. Even though there is textual indication for uts**ādana in prameha no studies on uts**ādanain DSPN are available. Hence the present study has been planned to assess the efficacy of uts**ādana in DSPN.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
35.00 Year(s) 至 70.00 Year(s)(—)

入选标准

  • 1.Participants fulfilling the diagnostic criteria 2.Aged 35 – 70 years 3.Gender- no discrimination 4.Participants who have given informed consent.

排除标准

  • 1.Known cases of other peripheral neuropathy 2.Participants with hypersensitivity of skin, dust allergy 3.Clinical evidence of active cardiovascular, respiratory, renal and cerebrovascular diseases 4.Clinically significant orthopedic, muscular, thyroid and peripheral vascular disorders 5.Active Diabetic foot ulcers, infection and amputation of lower limbs 6.Presence of edema in lower limb 7.H/O use of sedative treatments, hypnotics, anticonvulsants in the past 7 days 8.Pregnant and lactating women.

结局指标

主要结局

1. Neuropathy Total Symptom Score 6

时间窗: 0th, 15th, 29th day

2. Quantitative sensory test – Biothesiometer

时间窗: 0th, 15th, 29th day

3. Semmes Weinstein Monofilament testing

时间窗: 0th, 15th, 29th day

次要结局

  • 1. Symptom scoring Based on Ayurvedic symptomatology(2. Quality of Life assessment by Brief Pain Inventory (SF))

研究者

发起方
VPSV Ayurveda College Kottakkal
申办方类型
Other [Aided college]
责任方
Principal Investigator
主要研究者

Fahmitha Hanna C

VPSV Ayurveda College Kottakkal

研究点 (1)

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