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临床试验/CTRI/2024/07/070227
CTRI/2024/07/070227尚未招募2 期

An open clinical study to evaluate the effect of BHUNIMBADI CHURNA in Prameha Purvarup with special reference to Prediabetes

DR Deepika Suryawanshi1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月11日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
"To evaluate the effect of Bhunimbadi Churna in Prameha Purvarup with special reference to Prediabetes"

研究概览

简要总结

Ayurveda or the" Veda of life" stands for Indian system of Medicine. The aim of Ayurveda is prolongation of Healthy life, prevention of disease, senility of a person and help a person to attain the four principle aim that is Dharma, Artha, Kam and Moksha. Knowledge of Ayurveda enables one to understand, how to create this balance of body, mind and consciousness. Balance is the natural order, imbalance is the disorder. Health is order, disease is disorder. Within the body there is constant interaction between order and disorder. When we understand the nature and structure of disorder, one can reestablish order.

Prameha is one of the astamahagada described in Ayurveda samhita. This disease which was prevalence in ancient time as mahagada (a disease for which treatment is very difficult) is still most challenging disease in 21st century.

Kaphakrut ch sarvam (prameha) indicates that is vitiated kapha i.e. the main dosha and of all the dushyas it is medas that is primarily entity that is disturbed. According to shatkriyakala, sanchay, prakop, prasar and sthansanshray avastha represents purvarupavastha of disease. Prameha purvarupas are elaborately explained in Ayurveda granthas. In bruhattrayi, Acharya described 20 types of prameha on the basis of predominance of dosha. In samprapti of Prameha, all the three doshas get vitiated mainly kapha along with following dushyas: rasa, rakta, mansa, meda, majja, shukra, lasika, vasa and oaj,

In this era of globalisation, lifestyle is changing day to day. Irregular food habit, lack of exercise, excessive stress, disturbed sleep pattern eventually hampers metabolism giving rise to lifestyle disorders. Prediabetes is a stage which is characterized by blood glucose levels which are above normal but below the diabetes threshold [2] The prevalence of Prediabetes in adults in India is estimated to be 14% - Prediabetes is a precursor before the Diagnosis of DM. If one has Prediabetes we should take important step as early as possible.

Ayurveda samhitas have such wonderful formulations. The kalpa Bhunimbadi Churna is described in Charak chikitsasthan is one of them. Contents are 1) Bhunimba 2) Katuka, 3)Shunthi, 4) Marich, 5) Pippali, 6) Mustak, 7) Indrayava, 8) Chitrakmool, 9) Kutajsal.

This combination of drugs mentioned above helps in sampraptibhanga of prameha and it is easy to available. Taking all this consideration the study is taken up entitled "AN OPEN CLINICAL STUDY TO EVALUATE THE EFFECT BHUNIMBADI CHURNA IN PRAMEHA PURVARUP WITH SPECIAL REFERENCE TO PREDIABETES."

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
21.00 Year(s) 至 70.00 Year(s)(—)

入选标准

  • 1 Age between 21 years to 70 years. 2 Gender.
  • All 3 Subject who are willing to give written informed consent. 4 Patients having signs and symptoms of Prameha purvarupa like Swedatipravritti, Pipasa, Angasada, Nidradhikya and Karapadatala daha. 5 Newly diagnosed with Prediabetes 6 HbA1C 5.7-6.4% 7 BSL Fasting 110-125mg/dl 8 BSL PP140-199 mg/dl.

排除标准

  • 1 Prior use of medicine to treat diabetes.
  • 2 Pregnant and lactating women.
  • 3 Patients having complications like CKD, HIV, CA, acute conditions of CHD.
  • 4 Patients who are immunocompromised and who are on immunosuppressant medications.
  • 5 Those patients who are not ready to comply the trial protocol.

结局指标

主要结局

"To evaluate the effect of Bhunimbadi Churna in Prameha Purvarup with special reference to Prediabetes"

时间窗: Total duration of study: 10 Weeks: - With medicine - 6 Weeks Without medicine - 4 Weeks

次要结局

  • 1.To assess the effect of Bhunimbadi churna in symptoms like Nidradhikya, in symptoms like Atiswedpravritti, Pipasa, Nidradhikya, Angasada, Karapadatala daha.(Total duration of study: 10 Weeks: - With medicine - 6 Weeks Without medicine - 4 Weeks)

研究者

发起方
DR Deepika Suryawanshi
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Deepika Suryawanshi

R A PODAR AYURVEDIC MEDICAL COLLEGE WORLI MUMBAI 18

研究点 (1)

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