“Clinical Evaluation of Haridradi Avleha and Virechana Karma in the Management of Tamaka Shwasa w.s.r. to Bronchial Asthmaâ€
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Patients of both sexes between age group 18-60 of tamak shwasa will be selected for relieving signs and symptoms
研究概览
简要总结
This is open label randomised single centre trial comparing efficacy of Ayurvedic drug Haridradi Avleha 20 gram BD and Panchkarma Procedure Virechana Karma in the management Tamaka Shwasa (Bronchial Asthma).Patients of both sexes between age group 18-60 of tamak shwasa were selected for relieving signs and symptoms.30 clinically diagnosed and confirmed patients were randomly divided into two equal groups for the administration of trial drug.
Group A 15 patients were administered trial drug Haridradi Avleha in dose of 20 gm twice a day orally for 28 days. Group B 15 patients were performed Virechana Karma before the trial drug Haridradi Avleha 20 gm twice a day fo 28 days.
Thecurrent research work entitled as “ClinicalEvaluation of Haridradi Avleha and Virechana Karma in the Management of Tamaka Shwasa w.s.r. to BronchialAsthma†was carried out withfollowing aims and objectives.
AIMS & OBJECTIVES-
· To assess the effect of Haridradi Avleha and Virechana Karma in the management of Tamaka Shwasa.
· To study the comparative effect of Haridradi Avleha and Virechana Karma.
· To study pathophysiology and clinicalevaluation of Tamaka Shwasa.
In this studyfollowing observations and results are found:
Observations& Results: 17 patients inage group 18-30 years & 08 patients in age group 31-40 years were found; itshows overall 83.33% patients belonged to 2nd to 3rddecade of life. Incidenceof disease was found mildly higher in males (53.33%) than in females (46.67%). Majority of the patients (86.67%),belonged toHindu religion; 70% patients were married. Maximum36.67% patients were doing services and 33.33% patients were housewives. About40% patients belonged to Lower middle class and 33.33% patients belonged toMiddle class. Max. 60% Patients were of Vata-KaphajaPrakriti which is highly associated with the development of Tamaka Shwasa, 96.67% patients were of Madhyama Sara and 90% were having Madhyama Samhanan, 96.67% patients with Madhyama Satmya, 90% patients with Madhyama Satva, 66.67% patients showed Madhyama Ahara Shakti. 56.67% patientsshowed Avara Vyayama shakti, 46.67%patients of showed Madhyama nature ofKoshtha andmaximum43.33% patients had Mandagni. Inthis type of Kostha & Agni there is predominance of Kapha Dosha, which may play importantrole in developing the pathogenesis of TamakaShwasa.Maximum 60% patients had duration of illness < 5 yrs, 56.67% patients had positivedrug history of Allopathic medicine and 43.33% patients have positive familyhistory of the disease. Maximum 100% patients had breathlessness, 60% patients had dry cough, 33.33% patients had expectoration, 53.33% patients had wheezing, 33.33%had chest tightness, 53.33% had rhinitis, 50% had sneezing, 33.33% had anorexia,50% had disturbed sleep and 43.33% had paroxysms of dyspnoea due to seasonalchanges before the treatment.
Out of15 Patients, which were treated in ShodhanaPurvak Shamana, majority of cases had passed Madhyama Vega i.e. 11 to 20 times (60%). Thus they achieved Madhyama Shuddhi (60%).
**Resultsin the patients of Group A:InGroup A, patients treated with ‘Haridradi Avleha’ 20gm twiceaday with lukewarm water, before meal for 28 days showedhighly significant results regarding Subjectiveparameters – Shwasakricchata,Kasa,Nidralpata,Ghurghurakam, ACQ score with % relief of 72.55%, 75.86%, 46.43%, 68.42%, 61.66%respectively. In case of other Subjectiveparameters i.e. Pramoha there wassignificant result (P<0.05) with % relief of 89.47% and Bhashankricchatatherewas non significant results (P>0.05) with % relief of 87.50%.
InObjective parameters , PEFR hadshown significant result (p value<0.05) with an improvement of 29.61%, FEV1% had shown highly significant result improvementof 24.97% , while Hb% had shown nonsignificant results (P >0.05) with an improvement of only 3.08%. TLC hadshown non significant result (P>0.05) with an improvement of 7.56%.Eosinophil count had shown non significant result (P>0.05) with animprovement of 9.65%. TEC had shown non significant result (P>0.05) with animprovement of 7.26%. Lymphocyte count had shown significant result (P<0.05)with an improvement of 15.86%. In other laboratory parameters, there were nosignificant findings.
Resultsin the patients of Group B:
In Group B, patientswere performed Virechana Karma before the administration of trialdrug “Haridradi Avleha†20 gm twice a day orally with lukewarm water,before meal for 28 days. This group showed highly significant results regarding Subjective parameters – Shwasakricchata,Kasa,Pramoha, Nidralpata,Ghurghurakam*,* ACQ score with % relief of 76.00%, 77.27%, 96.77%, 86.11%,78.57%, 65.99%respectively. In case of other Subjectiveparameters i.e Bhashankricchatatherewas non significant results (P>0.05) with % relief of 69.23%.
InObjective parameters, PEFR hadshown significant result (p value<0.05) with an improvement of 35.10%, FEV1% had shown highly significant resultimprovement of 29.18% , while in case of Hb% non significant results (P >0.05) was seenwith an improvement of only 1.79%. TLC had shown non significant result(P>0.05) with an improvement of 0.58%. Eosinophil count had shown nonsignificant result (P>0.05) with an improvement of 18.56%. TEC had shown nonsignificant result (P>0.05) with an improvement of 16.32%. Lymphocyte counthad shown non significant result (P>0.05) with an improvement of 3.56%. Serumcreatinine had shown significant result (P<0.05) with an improvement of 9.68%.In other laboratory parameters, there were no significant findings.
Discussion-
The formulation selected in this trialwas chosen from Yogratnakar Shwasachikitsa (2)& contents of Haridradi Avleha are Haridra, Maricha, Draksha, Pippali , Shati, Rasna, Sarshapa Taila, Guda inthe proportion of 1:1:1:1:1:1:1:14.
In this combination, it is observed that themajority of ingredients of Haridradi Avlehaare having Vata-Kaphashamakaproperty like Haridra, Maricha, Pippali,Rasna etc. Thedrugs have a potential of alleviating Kaphaby Katu Rasa and Ushna Veerya, Laghu Tikshna and Ruksha Guna,and VataDosha by virtue of Ushna Veerya, Snigdha Guna of Guda, Mustard oil. Thus Kapha Shamaka properties of drug helpin breaking the Srotorodha anddigestion of Ama, which leads toproper functioning of the body.
Most drugs of HaridradiAvleha are having Tikta Rasa. Itcompleted the Pachana of Ama Dosha. This property controls theinitial Ama formation,if formed in any way it can be neutralized which is vital in preventing thedisease. Katu Rasa pacifies Kapha and Vata due to its Ushna,Tikshna, Vishada Guna. Vishada Guna helps in absorption of Kleda. Katu Rasa also helps in Deepana,Pachana, and Srotoshodhakaaction.
Most of the ingredients of Haridradi Avleha (Haridra, Rasna, Shati,Maricha & Pippali) have Ushna Veerya property, which will treat the Doshic pathology. From the action, it can be assumed that the drug is VeeryaPradhana indeed. That iswhy most of the contents of HaridradiAvleha are Kaph-Vatashamaka innature.
In Haridradi Avleha, Draksha, Guda arehaving Madhura Rasa, which helps inpacifying Vata Dosha. Madhura Rasabalances the Ushna, Tikshna & Ruksha Guna of other drugs by its Shita, Snigdha, Picchila,Guru Gunas. It also has Brimhanaproperties, that is required in the management of Tamaka Shwasa.
Some ingredients ofstudy drugs have Rasayana Prabhava (Pippali). The Rasayana drug is supposed to increase both qualitatively andquantitatively, all Dhatus of thebody
In Group B Virechana Karma procedure has been done.Virechana Karma procedure is best forPittaja Vyadhi. Although Tamaka Shwasa is not Pittaja Vyadhi but it is Pittasthana Samudbhav Vyadhi and Acharya Charaka has indicated Virechana Karma in Tamaka Shwasa as ‘Tamke tuVirechanam’ in Charaka SamhitaChikitsasthana 17/121. So the ShodhanaKarma is necessary to remove the obstruction of Kapha in the passage of Vata.
The drug used for the Virechana Karma is AbhyadiModak. As Acharya Charaka hassaidthat the Virechana should be done with‘Vatashleshmahara dravya’ So AbhyadiModak has been used because most of the drugs of Abhyadi Modak are UshnaVeerya, hence possessVatakaphashamaka property.
Most of the drugs of Abhyadi Modak are Katu, Tikta Rasa dominant like Trivrutta,Danti, Mustak, Pippalimoola, Pippali etc. which possess the Deepana Pachana property, hence these drugs are used for Aampachana.
Most of the drugs are Laghu, Rukshna, Tikshna Guna dominant, hencepossess Kaphaghna property which helpsin Srotoshodhana.
Virechana helps in Vatanulomana thus help in correcting the Pratilomgati of Vayu. Virechana causes Deeptagni,Indriyaprasadan, Dosha Samyata also*.*
Virechana Karma decreases waterand electrolyte absorption deplete extracellular fluid to lesser extent therebydecreasing blood pressure. VirechanaKrama removes undigested food material and prevents stimulation ofinflammatory mediators.
v CONCLUSION
The Tamaka Shwasa is Vyadhi of Pranvaha Srotas,Vata-Kaphaja in nature. It is a Pittasthanasamudbhava Vyadhi and Yapya in nature. It is correlated withmodern entity Bronchial Asthma due to its similarity in signs and symptoms and causativefactors.
v It can be concluded that hypo-functioning of Agni otherwise termed as Mandagni is largely responsible for the formationof Ama which is chief pathogenic factor of the disease.
v Tamaka Shwasa is the diseasehaving Vata and Kapha predominance. But, in fact itis Tridoshaja in origin from Adhoamashaya (Pittasthanasamudbhava).
v HridradiAvleha (Group A)- has provided better relief in most of the symptomsof the disease like Shwasakricchata, Kasa,Nidralpata, Ghurghurakam at highlysignificant level. Pramoha atsignificant level. It shows highly significant result in ACQ score.
v Group A has showed highly significant resultin objective parameters FEV1% and significant result in PEFR.
v Virechana Karma with Vata-ShleshmaharaDravyas is mentioned in classical texts. Virechana Karma balances all the three Doshas in equilibrium. It removes the unwanted waste material andtoxins from the body. It purifies the body and makes it healthier. Samsarjana Karma after Virechana is very necessary because bodyis not able to digest Guru Ahara, henceLaghu Ahara is advised for 3-7 daysaccording to Shuddhi. After Shodhana Karma the Shamana Aushadi works more effectively.
v Virechana Karmaand Haridradi Avleha (Group B):- GroupB has provided better relief in mostof the symptoms of the disease like Shwasakricchata, Kasa, PramohaNidralpata, Ghurghurakam at highly significantlevel. It shows highly significant result in ACQ score.
v Group B has showed highly significant resultin objective parameters FEV1% and in PEFR.
v Thestudy has revealed that there was no adverse effect on renal and liver functiontests, with which it can be concluded that the drug Haridradi Avleha and procedure VirechanaKarma are safe for use in the patients of Tamaka Shwasa (Bronchial Asthma).
v On comparing the effect of two therapiesit can be concluded that GroupB (Virechana Karma & Haridradi Avleha)provided better relief than Group A (HaridradiAvleha) in most of the sign and symptomsof the disease at significant level.
v Thusit can be concluded that Haridradi Avlehaand Virechana Karma can be usedas effective and safe therapeutic agents in the management of Tamaka Shwasa (Bronchial Asthma).
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 60.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients willing for trial and give consent.
- •2.Patients of age group 18 to 60 years of either sex.
- •3.Patients having signs and symptoms of Tamaka Shwasa (Bronchial asthma) as mentioned in Ayurvedic and Modern texts.
- •4.Patients fit for Virechana Karma.
排除标准
- •1.Patients not willing for trial.
- •2.Age below 18 and above 60years of either sex.
- •3.Patients suffering from Pulmonary Tuberculosis, Anaemia, Bronchus/Bronchogenic carcinoma, Chronic obstructive pulmonary disease, Pleural effusion.
- •4.Status asthmaticus.
- •5.Patients with rectal or vaginal prolapse.
- •6.Pregnant and lactating women.
- •7.Pateints suffering from serious systemic disorders like renal diseases, heart diseases, malignant hypertention, Diabetes Mellitus.Patients who are unfit for Virechana Karma.
结局指标
主要结局
Patients of both sexes between age group 18-60 of tamak shwasa will be selected for relieving signs and symptoms
时间窗: Patients of both sexes between age group 18-60 of tamak shwasa will be selected for relieving signs and symptoms
次要结局
- Assess the comparative efficacy between Haridradi Avleha and Virechana Karma after 4 weeks in case of Tamaka Shwasa(Assess the comparative efficacy between Haridradi Avleha and Virechana Karma after 4 weeks in case of Tamaka Shwasa)
