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临床试验/CTRI/2025/07/090583
CTRI/2025/07/090583尚未招募1/2 期

AN OPEN LABEL RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE COMBINED EFFECT OF MATRABASTI,PADABHYANGA AND SRINRIPATIVALLABHA RASA IN DIABETIC PERIPHERAL NEUROPATHY

Self1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月25日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
Self
入组人数
40
试验地点
1
主要终点
Reducing sign and symptoms of Diabetic Peripheral Neuropathy through Matrabasti with Dhanvantaragritha,Padabhyanga with Chandanadi taila and Srinripativallabharasa

研究概览

简要总结

Diabetes Mellitus is a metabolic disorder of multiple etiologies. It is characterized by chronic hyperglycemia together with disturbance of carbohydrate, fat and protein metabolism resulting from defect of insulin secretion, insulin action or both.These are associated with the development of specific microvascular complication such as retinopathy, nephropathy and neuropathy.

Diabetic Peripheral Neuropathy[DPN] is one of the most common microvascular complication of Diabetes Mellitus and a major cause of morbidity. About 50% of Diabetic population are affected by Diabetic Peripheral neuropathy[DPN]. Patients with Type 2 Diabetes Mellitus are more often affected than those with Type1. In India, prevalence of Diabetic Peripheral Neuropathy ranges from 15 to 60%.

The TORONTO consensus meeting, defined Diabetic Peripheral Neuropathy[DPN] as asymmetrical and length-dependent sensorimotor polyneuropathy attributed to metabolic and micro-vascular alteration, as a result of long-standing hyperglycemia and metabolic derangements.

Common clinical features of Diabetic Peripheral Neuropathy[DPN] are diminished perception of vibration sensation distally, glove and stocking impairment, loss of tendon reflexes in lower limbs, paranesthesia in the feet(and, rarely, in the hands), pain in the lower limbs(dull, aching and/or lancinating, worse at night, and mainly on the anterior aspect of the legs), burning sensation in soles of the feet, cutaneous hyperesthesia and an abnormal gait and often associated with a sense of numbness in the feet. Management of Diabetic Peripheral Neuropathy includes strict glycemic control(life style modification and intensive insulin therapy) anticonvulsants, antidepressants and opiates. But the treatment is unsatisfactory in most of the respect. Hence its a need of hour to throw a light on effective and feasible treatment for Diabetic Peripheral Neuropathy[DPN].

Based on the clinical features of Diabetic Peripheral Neuropathy[DPN], it can be inferred that there is vitiation of Vata Pitta pradhana tridosha.

Basti is the prime treatment modality for Vata vyadhi. Acharya Sushrutha quotes that Basti is not only indicated for Vata Dosha, but also beneficial for Pitta, Kapha and Raktha Doshas. In present study, Dhanvantara Gritha mentioned in Astanga-Hrudaya Prameha chikista, indicated in Prameha pidaka, Madhumeha, Shotha and Vatashonita it is selected for Matra Basti.

Focusing on the clinical feactures of Diabetic Peripheral Neuropathy[DPN], Chandanadi taila is selected for Padabhyanga, it is indicated in Angadaha and vatarakta.

Srinrupativallabha Rasa mentioned in Grahani Rogadhiraka of Bhaishajya Ratnavali having indication in Prameha,Daha,Vatarakta,Shotha also having karma of Ayushya, Balya & Veerya vardhaka is selected as the Shamanoushadi .

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
30.00 Day(s) 至 70.00 Day(s)(—)
性别
All

入选标准

  • Subjects fulfilling diagnostic criteria. Subjects with HbAlc between 7% to 11%. Subjects between the age group of 30-70 years irrespective of gender, religion and socio-economic status. Both fresh and treated cases. (Fresh case.
  • include freshly diagnosed and untreated cases of DPN.Treated case.
  • include already diagnosed and treated cases of DPN who had voluntarily discontinued the treatment with the flush out period of 7 days).

排除标准

  • Subjects with other complications of Diabetes mellitus like nephropathy, wounds, foot ulcers and gangrene.
  • Stage 5 of Diabetic Peripheral Neuropathy.
  • Pregnant Women and Lactating Mothers.
  • Subject with any other systemic disorders which interfere with the intervention such as Cardiac Disorder, Cancer, Arterial Diseases, Alcoholism, Drug abuse, Renal insufficiency and Hepatitis.

结局指标

主要结局

Reducing sign and symptoms of Diabetic Peripheral Neuropathy through Matrabasti with Dhanvantaragritha,Padabhyanga with Chandanadi taila and Srinripativallabharasa

时间窗: Reducing sign and symptoms of Diabetic Peripheral Neuropathy through Matrabasti with Dhanvantaragritha,Padabhyanga with Chandanadi taila and Srinripativallabharasa

次要结局

  • Reducing of blood glucose level(In 3 month of duration)

研究者

发起方
Self
申办方类型
Other [nil]
责任方
Principal Investigator
主要研究者

DrVijayajyoti Sagarappa Janakapuri

JSS Ayurveda Medical College and Hospital Mysore

研究点 (1)

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