“ A clinical trial to study the effects of Virechana Karma, and Haridradi Avleha in the patient having symptomts of Tamaka Shwasa w.s.r to Bronchial Asthma. â€
- Conditions
- Patients having symptoms of tamaka shwasa (Bronchial Asthma)
- Registration Number
- CTRI/2017/12/010920
- Lead Sponsor
- National Institute of Ayurveda
- Brief Summary
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*â€*** 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 of*Koshtha* 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 *Bhashankricchata*therewas 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 Avlehaâ€* 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 *Bhashankricchata*therewas 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 Avleha*are having *Vata-Kaphashamaka*property 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 *Srotoshodhaka*action.
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 Rasa*balances the *Ushna,* *Tikshna* & *Ruksha Guna* of other drugs by its *Shita, Snigdha*, *Picchila,Guru Gunas*. It also has *Brimhana*properties, 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 for*Pittaja 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, h*ence possess*Vatakaphashamaka* 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,* hence*Laghu Ahara* is advised for 3-7 daysaccording to *Shuddhi.* After *Shodhana Karma* the *Shamana Aushadi* works more effectively.
v ***Virechana Karma***and ***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** **c****o****mparing 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 Avleha*and *Virechana Karma* can be usedas effective and safe therapeutic agents in the management of *Tamaka Shwasa* (Bronchial Asthma).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patients of both sexes between age group 18-60 of tamak shwasa will be selected for relieving signs and symptoms Patients of both sexes between age group 18-60 of tamak shwasa will be selected for relieving signs and symptoms
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
National Institute of Ayurveda, Jaipur
🇮🇳Jaipur, RAJASTHAN, India
National Institute of Ayurveda, Jaipur🇮🇳Jaipur, RAJASTHAN, IndiaDr Ajay Kumar SahuPrincipal investigator9950708106drajaysahu@gmail.com