CLINICAL EVALUATION OF ‘SAPTAMRITA VATI’ AND ‘VIRECHANAKARMA’ IN THE MANAGEMENT OF TAMAKA SHWASA W.S.R. TO BRONCHIAL ASTHMA
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
- Improvement in clinical Symptoms of Tamaka Shwasa
研究概览
简要总结
Disease reference-
Agnivesha, Charakasamhita, ChikitsaSthana, Hikkashwasa ChikitsaAdhyaya,
Drug reference-
1.RasRatna Sammuchaya, Hikka Shwasa Chikitsa prakran 13/56,57,58,59 )
2. virechanakarma reference-,Hikkashwasa Chikitsa Adhyaya, 17/21,
3. ibidem, Charakasamhita, PanchkarameeyaSiddhi Adhayya 2/11, pg. no. 688
- ibidem, Ashtanga Hridaya, DoshoparkramaneeyaAdhayaya 13/29,pg.no. 217
5. ibidem, Charakasamhita, Siddhisthana, Kalpana SiddhiAdhayya 1/6, pg. no. 677
ch.su 16/7-8.
NEED OF STUDY:
Current estimate suggest that 300 million people worldwide suffer from Asthmaand an additional 100 million may be diagnosed with asthma by 2025. Accordingto WHO, by the year 2020 asthma along with chronic obstruction pulmonarydisease will become the third leading cause of death8. With anestimated 1.5-2 crores asthma patients, at least one in every 10 asthma patientglobally lives in India. Globally, the economic costs associated with asthmaexceed those of TB and HIV/AIDS combined. Asthma is prevalent in all countries,whether they are developed or underdeveloped. In fact, over 80 percent ofasthma deaths according to the World Health Organization (WHO), occur in lowand lower-middle-income countries9.
Line of treatment adopted in Bronchial Asthma includes the use of inhaler ofcorticosteroids, leukotriene receptor antagonist, methylxanthinesetc. After taking modern drugs patient quality of life still remainscompromised10.
As per Ayurvedicclassics main line of treatment for Tamaka Shwasa includebothShodhanaandShamana Chikitsa, Acharya Charak has described the Shodhana procedure as
“ ***तमके******तà¥******विरेचनमà¥***“ 11
In Shamana Chikitsa the food or drug which isVata Karakaand Kapha Nashaka or KaphaKarakaand Vata Shamakais indicated and in singlearm treatment only Vata Shamaka or Kapha Shamaka Chikitsa isindicated.12
Variety of treatment modalities including Shamanaand Shodhana have been described in Ayurvedaformanagement of Shwasa Roga.
Considering these factors this study hasbeen planned to evaluate the efficacy of Virechana Karma and SaptamritaVati in Tamaka Shwasa.
HYPOTHESIS:
Null Hypothesis [H0]
Saptamrita Vati and Virechana Karma areequally effective in Tamaka Shwasa (BronchialAsthma).
Alternate Hypothesis[H1]
Saptamrita Vati and Virechana Karma arenot equally effective in Tamaka Shwasa(Bronchial Asthma)
FOLLOW UP- 0,15th and 30th day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients willing for trial and give consent.
- •2.Patients of age group 18 to 70 yrs of either sex.
- •3.Patients having signs and symptoms of Tamak Shwasa i.e., Shwasakrucchata, Kasa (cough), Pratishyaya (chronic rhinitis), Bhasankrucchata (difficulty in speech), Nidralpata (inadequate sleep), Ghurghuraka (audible sounds) 4.Patients fit for Virechana Karma.
- •5.Patients who is not taking any allopathic medication for Asthma.
- •Mild & moderate cases of Bronchial Asthma.
排除标准
- •1.Patients not willing for trial.
- •2.Age below 18 years and above 70 years of age of either sex.
- •3.Patients suffering from Pulmonary tuberculosis, Cardiac Asthma, Bronchogenic carcinoma, Chronic obstructive Productive disease, Pleural effusion 4.Status Asthmaticus 5.Patients suffering from serious heart diseases or any other serious health aliment.
- •6.Patient with rectal or vaginal prolapse 7.Pregnant and lactating women 8.Patients, who are unfit for Virechana Karma 9Patients, who is taking any allopathic medication for Asthma.
结局指标
主要结局
Improvement in clinical Symptoms of Tamaka Shwasa
时间窗: 30 days
次要结局
- 1.Changes in Asthma control questionnaire(2. Changes in Spirometry- FVC1% and PEFR)