The efficacy of Shatyadhi churna in the management of vataja pratisyaya (allergic rhinitis) in children- A randomized controlled clinical trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in the severity of cardinal feature of Vataja pratisyaya with respect to allergic rhinitis.
研究概览
简要总结
INTRODUCTION
Allergic rhinitis is the most common chronic disorder inthe pediatric population which has a profound impact on the daily lives ofchildren resulting in day-time fatigue, impairment of cognition and memory,irritability, sadness, impairment of sleep and limitation of activities atschool as well as home. This trial is an attempt to provide an effective formof therapy among children by evaluating the efficacy of a herbal formulation ofSati, Amalaki and Trikatu in the form of churna along with guda and ghrita tobe given orally in comparison to contemporary third generation drug SyrupLevocitirizine on Vataja pratisyaya with respect to allergic rhinitis.
OBJECTIVES OF THE RESEARCH
PRIMARY:
1.Reduction in the severity of cardinal feature of Vatajapratisyaya with respect to allergic rhinitis among children .
SECONDARY:
1.Reduction in nasal smear eosinophile count and IgE level.(Due to COVID-19 pandemic constraints, Nasal smear eosinphile count was nottaken)
2.Improvement in the Pediatric Rhinoconjunctivitis Qualityof Life Questionnaire (PRQLQ) Overall Score at the End of the Treatment Period.[Time Frame: Weeks 0 - 4]
Improvement in the Adolescent Rhinoconjunctivitis Qualityof Life Questionnaire (AdolRQLQ) Overall Score at the End of the TreatmentPeriod. [Time Frame: Weeks 0 - 4]
3.Improvement in Average Daily Subject Reported AM and PMReflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Treatment Period[Time Frame: Weeks 0 - 4 ].
4.Improvement in Average Daily Subject-reported AM and PMReflective Total Ocular Symptom Scores (rTOSS) Over the 2-week TreatmentPeriod. [Time Frame: Weeks 0 - 4].
METHODOLOGY
STUDY DESIGN: OPEN LABEL RANDOMIZEDCONTROLLED CLINICAL TRIAL
Sample size-60 (30 each group)
Group A: oral administration of Shatyadhi churna with gudaand ghrita.
Age 6-11years- 5gm, daily in 2 divided doses
Age 12-16years – 6.5 gm, daily in 2 divided doses
Duration: 4 weeks.
Group B: oral administration of syrup Levocetirizine(2.5mg/5ml).
Age 6-11 years -5 ml once a day in evening
Age 12-16 years- 10ml once a day in evening
Duration: 2 weeks.
Follow up: 1 month
RESULT
The trial drug was found to be significantly effective inreducing the cardinal features of VÄtaja PratiÅ›yÄyawithin thegroup but on comparison with the control drug no significant difference wasobtained.
In Group A IgE level significantly reduced within thegroups, whereas no significant reduction was noted on comparison with the othergroup.
In Group-A, 10 out of 16 patients and in Group-B, 6 out of14 patients belong to age group 6- 12 years, thus they were subjected toPediatric Rhino-conjunctivitis Quality of life questionnaire. Whereas 6 out of16 patients of Group-A and 6 out of 14 patients Group-B belong to age group 12-16 years, thus they were subjected to Adolescent Rhino-conjunctivitis Qualityof life questionnaire. There was significant improvement in Quality of lifewithin each group but none of the group was found to be effective than theother.
Åšaá¹yÄdhicÅ«rṇawasable to effectively reduce the Total Nasal Symptom Score and Total OcularSymptom Score within the trial group but could not be significantly effectivethan the Syrup Levocetirizine.
Afterthe follow-up the symptoms reoccurred in many of the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 6.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group 6 to 16 years irrespective of their sex.
- •Patients having following 4 or more diagnostic symptoms of vatajapratishaya ie.
- •a)Kshavathu(sneezing), b)nasa srava(rhinorrhea), c)Nasauparodha(nasa blockage) , d)mukha shosha(dry mouth) , e)sirasoola(headache) , f)nasa –bru kandu(itchy nose –eyebrow) -for a minimum of one year immediately preceding the study Screening Visit.
- •A minimum score of 4 on Vataja pratisyaya severity score index will be included in the study.
- •Gives written informed consent (parent/legal guardian) and assent (from the child), including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
排除标准
- •1.Age under 6 years and above 16 years irrespective of sex.
- •2.Patients having lower respiratory tract infection.
- •3.Upper Respiratory complaints such as Nasal polyposis, Nasal tumours.
- •4.Patients with adenotonsillar hypertrophy, craniofacial syndromes, or neuromuscular diseases.
- •5.Patients with history of nasal surgery.
- •6.Other respiratory infectious conditions such as Tuberculosis, Plural effusion, Emphysema, Lung abscess, Bronchiectasis, pneumonia, Pleurisy.
- •7.Congenital anomalies of respiratory tract or rhinitis due to trauma.
- •8.Patients suffering from chronic debilitating diseases like JDM, HIV, HBsAg, immune compromised children etc.
- •9.Patients who are not willing to be included in the study protocol and also who are not willing to give the consent for the study.
结局指标
主要结局
Reduction in the severity of cardinal feature of Vataja pratisyaya with respect to allergic rhinitis.
时间窗: 0 day, 8th day, 15th day, 22nd day, 29th day. allergic rhinitis and during follow up.
次要结局
- 1.Decrease in the nasal smear eosinophil count and IgE level.(2.Improvement in the Quality of Life of children in both the groups according to AdolRQLQ and PRQLQ.)