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临床试验/CTRI/2022/08/044853
CTRI/2022/08/044853尚未招募2/3 期

A Clinical Study To Evaluate The Efficacy Of Bharngimool Arka Nebulization And Sinhyadi Kwath In The Management Of Tamaka Shwasa In Children

Shri Krishna Governement Ayurvedic College and Hospital kurukshetra1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年9月20日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Change in subjective and objective criterias of Tamaka Shwasa

研究概览

简要总结

Tamak Shwasa is one of the varities among five types of shwasa.It is mentioned as disease of pranvaha srotas. Environmental pollution comprising of excess smoke, dust particles, seasonal changes,extreem cold, pollen and toxic materials vitiate the prana vayu along with kapha. It can manifest either in vaigika or avaigika state due to presence of kapha vata dosha. With the expulsion of kapha patient gets relief for some time. Shodhana and shaman are used for its treatment. Shamana chikitsa will be used to treat children  as Bharangi mool arka as herbal nebulizer and Sinhyadi kwatha for oral administration. Sinhyadi kwatha  is mentioned in yoga ratnakar and Bharangi mool arka is taken for study. All children of age group 3 to 16 are selected from the opd of shri krishna govt ayurvedic College and hospital. Children below 3 and above 16,other chronic illnesses, children with congenital abnormality are excluded from the study. Maximum 30 patients are taken in two groups, each group has 15 patients. Group A is adviced for inhalation og Bharangi mool arka and group B is adviced for oral ingestion of Sinhyadi kwatha and inhalation of Bharangi mool arka. After completing the trial for 21 days children will be assessed again after 30 days for 2 months to access the efficacy of the trial.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
3.00 Year(s) 至 16.00 Year(s)(—)
性别
All

入选标准

  • Children of age group of 3 -16 years irrespective of caste, sex, religion.
  • Presence of classical symptoms of Tamak Shwasa like: Ghurghurkanvitam(wheezing), Shwasakashtata (shortness of breath), Aasino labhyate Saukhayam (relief in sitting position), Kasa(cough), Jawara abhibhut (associated with fever).
  • Parents of children are willing to participate in research trial.

排除标准

  • 1.Patients presenting with severe symptoms of Tamak Shwasa (Bronchial asthma).
  • Any chronic illness, systemic disease like; TB, Respiratory Distress Syndrome, Chronic lung disease, Bronchiectasis, Pleurisy, CHD, Acute Diarrhoea,Septic Shock etc will be excluded from the study.
  • Children with any congenital abnormality.
  • History of food or drug allergy of any kind.
  • During course of treatment if the patient develops any acute illness requiring acute management, such patients will be excluded from the study and continued with conventional treatment.
  • Patients below age of 3 years and above 16 years.

结局指标

主要结局

Change in subjective and objective criterias of Tamaka Shwasa

时间窗: Group A- 15 min of nebulization thrice a day for 21 days. | Route of administration - inhalation | Dose- 2 ml respule | Follow up - Follow up will be done monthly for two months | Group B - 15 min of nebulization thrice a day along with oral medication twice a day for 21 days. | Route of administration - inhalation and oral | Dose- 2 ml respule and 1.2ml/kg/day | Follow up - Follow up will be done monthly for two months .

次要结局

  • 1. To develop a safe and effective drug that can be helpful for asthmatic community.(2. To study etiopathogenesis of Tamak Shwasa from Ayurveda and Modern point of view.)

研究者

发起方
Shri Krishna Governement Ayurvedic College and Hospital kurukshetra
申办方类型
Government medical college

研究点 (1)

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