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临床试验/CTRI/2024/04/065329
CTRI/2024/04/065329尚未招募2/3 期

Efficacy of Haridrakhanda orally with and without shunthyadi Taila Nasya in the management of Vataja Pratishyaya(Allergic Rhinitis)- An open Labelled Randomized comparative clinical trial

ITRA Jamnagar1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年4月15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
Reduction in subjective and objective criterias assessed

研究概览

简要总结

Many research work have been carried out on Vataja Pratishyaya(Allergic Rhinitis) in Ayurveda and in contemporary system of medicine, Vataja Pratishyaya(Allerigc Rhinitis) still remain as a hazardous problem as it has more chances of recurrent episodes and serious complication. Haridrakhanda has Rasayana and Rogahara property. It may gives an immune modulator effect which will be effect on symptoms of Pratishyaya(Allergic Rhinitis). Nasya with Shunthyadi Taila will have great effect on symptoms of Pratishyaya, as Nasa is considered as direct gateway to the shirah. Information on the trial procedure and Drug; Here, in Group A**,** we are giving 6gm of Haridrakhanda twice a day with lukewarm water before meal In Group B, 6gm of Haridrakhanda twice a day with lukewarm water before meal and 6drops of Shunthyadi Taila Nasya in each nostril in morning(3 sitting of Nasya for 7 days each with interval of 3days). We assure that we will prepare formulation with as per S.O.P. in the Pharmacy of I.T.R.A. Description of the Process: In pesent study, participants who will be clinically diagnosed and confirmed cases of Vataja Pratishyaya(Allergic Rhinitis) enlisted in inclusion criteria will be enrolled minimum 30 patients and will be divided in to 2 groups by computer gnerated randmozation technique, having minimum 15 patients in one group. In Group A, they will be given 6gm of Haridrakhanda twice a day with lukewarm water before meal, In Group B, 6gm of Haridrakhanda twice a day with lukewarm water before meal and Shunthyadi Taila Nasya in each nostril in morning(3 sitting of Nasya for 7days each with interval of 3days) Follow-up: Follow up will be for one month duration at interval of 15 days. Side Effects: We will follow closely and keep track of any unwanted effects. we may use some other medicines or stop the usage of drug to decrease the symptoms of the side effects. Results: The efficacy of the therapy will be assessed on the basis of subjective criteria. Benefits

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
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Paients between age group of 18 and 50years.The diagnosis of the disease of Vataja Paratishyaya (Allergic Rhinitis) i.e. Gala-Talu-Oshtha shosha(Dryness), Svaropghata(Hoarseness of voice), Kshavathu(Sneezing), Nasa Srava(Nasal discharge) and Nasavarodha(Nasal obstruction).

排除标准

  • Patients below 18 and above 50years.
  • 1.Cases which require surgical intervention like polys would be excluded.
  • 2.Patients suffering from any chronic debilating disease like Tuberculosis, Diabetes Mellitus, Asthma and other Respiratory or Nasal problems.
  • 3.Patient having other type of rhinitis will be excluded on clinical feature and blood reports.
  • Patients taking any steroid more than 1week.

结局指标

主要结局

Reduction in subjective and objective criterias assessed

时间窗: 4-8weeks

次要结局

  • Prolonged effect of ayurvedic intervention in thé management of Vataja Pratishyay(Allergic Rhinitis)(4-8weeks)

研究者

发起方
ITRA Jamnagar
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sarita M Sosa

Institute of Teaching and Research in Ayurveda

研究点 (1)

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