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CTRI Number  CTRI/2017/12/010920 [Registered on: 20/12/2017] Trial Registered Retrospectively
Last Modified On: 21/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   “ 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. ” 
Scientific Title of Study   “Clinical Evaluation of Haridradi Avleha and Virechana Karma in the Management of Tamaka Shwasa w.s.r. to Bronchial Asthma” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ajay Kumar Sahu 
Designation  Assistant Professor 
Affiliation  National Institute of Ayurveda 
Address  P.G Department of Kayachikitsa National Institute of Ayurveda ,Jorawar Singh gate ,Madhav Vilas Palace Amer Road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9950708106  
Fax    
Email  drajaysahu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Niharika Shakya 
Designation  M.D. Scholar 
Affiliation  National Institute of Ayurveda 
Address  P.G Department of Kayachikitsa National Institute of Ayurveda ,Jorawar Singh gate ,Madhav Vilas Palace Amer Road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9451582647  
Fax    
Email  nshakya012@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Niharika Shakya 
Designation  M.D. Scholar 
Affiliation  National Institute of Ayurveda 
Address  P.G Department of Kayachikitsa National Institute of Ayurveda ,Jorawar Singh gate ,Madhav Vilas Palace Amer Road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9451582647  
Fax    
Email  nshakya012@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Jaipur 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Near Jorawar Singh Gate, Madhav Vilas Palace Amer Road Jaipur Rajasthan 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Niharika Shakya  National Institute of Ayurveda Near Jorawar Singh Gate, Madhav Vilas Palace Amer Road Jaipur Rajasthan 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ajay Kumar Sahu  National Institute of Ayurveda, Jaipur  Jorawar Singh gate ,Madhav Vilas Palace Amer Road Jaipur Rajasthan
Jaipur
RAJASTHAN 
9950708106

drajaysahu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee National Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients having symptoms of tamaka shwasa (Bronchial Asthma),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Haridradi Avleha  Haridradi Avleha 20 gram twice a day orally before meal for 28 days. 
Comparator Agent  Virechana Karma  Virechana Karma with 2-3 tab (250 mg each tab) of Abhyadi Modak given before the trial drug Haridradi Avleha 20 gram twice a day orally before meal for 28 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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.

 
 
ExclusionCriteria 
Details  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.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   06/10/2017 
Date of Study Completion (India) 15/03/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not published yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  
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. 

The current research work entitled as “Clinical Evaluation of Haridradi Avleha and Virechana Karma in the Management of Tamaka Shwasa w.s.r. to Bronchial Asthma” was carried out with following 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 clinical evaluation of Tamaka Shwasa.

In this study following observations and results are found:

Observations& Results: 17 patients in age group 18-30 years & 08 patients in age group 31-40 years were found; it shows overall 83.33% patients belonged to 2nd to 3rd decade of life. Incidence of disease was found mildly higher in males (53.33%) than in females (46.67%). Majority of the patients (86.67%), belonged to Hindu religion; 70% patients were married. Maximum 36.67% patients were doing services and 33.33% patients were housewives. About 40% patients belonged to Lower middle class and 33.33% patients belonged to Middle class. Max. 60% Patients were of Vata-Kaphaja Prakriti 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% patients showed Avara Vyayama shakti, 46.67% patients of showed Madhyama nature of Koshtha and maximum 43.33% patients had Mandagni.  In this type of Kostha & Agni there is predominance of Kapha Dosha, which may play important role in developing the pathogenesis of Tamaka Shwasa. Maximum 60% patients had duration of illness < 5 yrs, 56.67% patients had positive drug history of Allopathic medicine and 43.33% patients have positive family history 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 seasonal changes before the treatment.

Out of 15 Patients, which were treated in Shodhana Purvak Shamana, majority of cases had passed Madhyama Vega i.e. 11 to 20 times (60%). Thus they achieved Madhyama Shuddhi (60%).

Results in the patients of Group A:  In Group A, patients treated with ‘Haridradi Avleha’ 20gm twice a day with lukewarm water, before meal for 28 days showed highly significant results regarding Subjective parameters – Shwasakricchata, Kasa, Nidralpata, Ghurghurakam, ACQ score  with % relief of 72.55%, 75.86%, 46.43%, 68.42% , 61.66% respectively. In case of other Subjective parameters i.e. Pramoha there was significant result (P<0.05) with % relief of 89.47% and Bhashankricchata there was non significant results (P>0.05) with % relief of 87.50%.  

In Objective parameters , PEFR had shown  significant result (p value <0.05) with  an  improvement of 29.61%, FEV1% had shown highly significant result improvement of 24.97% , while  Hb%  had shown non significant results (P >0.05) with an improvement of only 3.08%. TLC had shown non significant result (P>0.05) with an improvement of 7.56%. Eosinophil count had shown non significant result (P>0.05) with an improvement of 9.65%. TEC had shown non significant result (P>0.05) with an improvement of 7.26%. Lymphocyte count had shown significant result (P<0.05) with an improvement of 15.86%. In other laboratory parameters, there were no significant findings. 

Results in the patients of Group B:

In Group B, patients were performed Virechana Karma before the administration of trial drug “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 Subjective parameters i.e Bhashankricchata there was non significant results (P>0.05) with % relief of 69.23%.  

In Objective parameters, PEFR had shown  significant result (p value <0.05) with  an  improvement of 35.10%, FEV1% had shown highly significant result improvement of 29.18% , while in case of Hb%  non significant results (P >0.05) was seen with 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 non significant result (P>0.05) with an improvement of 18.56%. TEC had shown non significant result (P>0.05) with an improvement of 16.32%. Lymphocyte count had shown non significant result (P>0.05) with an improvement of 3.56%. Serum creatinine 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 trial was chosen from Yogratnakar Shwasachikitsa (2) & contents of Haridradi Avleha are Haridra, Maricha, Draksha, Pippali , Shati, Rasna, Sarshapa Taila, Guda in the proportion of  1:1:1:1:1:1:1:14.

In this combination, it is observed that the majority of ingredients of Haridradi Avleha are having Vata-Kaphashamaka property like Haridra, Maricha, Pippali, Rasna etc.  The drugs have a potential of alleviating Kapha by Katu Rasa and Ushna Veerya, Laghu Tikshna and Ruksha Guna, and Vata Dosha by virtue of  Ushna Veerya, Snigdha Guna of Guda, Mustard oil. Thus Kapha Shamaka properties of drug help in breaking the Srotorodha and digestion of Ama, which leads to proper functioning of the body.

           Most drugs of Haridradi Avleha are having Tikta Rasa. It completed the Pachana of Ama Dosha. This property controls the initial Ama formation, if formed in any way it can be neutralized which is vital in preventing the disease. Katu Rasa pacifies Kapha and Vata due to its Ushna, Tikshna, Vishada GunaVishada 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 Veerya Pradhana indeed. That is why most of the contents of Haridradi Avleha are Kaph-Vatashamaka in nature.

 In Haridradi Avleha, Draksha, Guda are having Madhura Rasa, which helps in pacifying 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 of study drugs have Rasayana Prabhava (Pippali). The Rasayana drug is supposed to increase both qualitatively and quantitatively, all Dhatus of the body

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 tu Virechanam’ in Charaka Samhita Chikitsasthana 17/121. So the Shodhana Karma is necessary to remove the obstruction of Kapha in the passage of Vata.

    The drug used for the Virechana Karma is Abhyadi Modak. As Acharya Charaka has said that the Virechana should be done with ‘Vatashleshmahara dravya’ So Abhyadi Modak has been used because most of the drugs of Abhyadi Modak are Ushna Veerya, hence 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, hence possess Kaphaghna property which helps in Srotoshodhana.

      Virechana helps in Vatanulomana thus help in correcting the Pratilomgati of Vayu. Virechana causes Deeptagni, Indriyaprasadan, Dosha Samyata also.

     Virechana Karma decreases water and electrolyte absorption deplete extracellular fluid to lesser extent thereby decreasing blood pressure. Virechana Krama removes undigested food material and prevents stimulation of inflammatory 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 with modern entity Bronchial Asthma due to its similarity in signs and symptoms and causative factors.

v It can be concluded that hypo-functioning of Agni otherwise termed as Mandagni is largely responsible for the formation of Ama which is chief pathogenic factor of the disease.

v Tamaka Shwasa is the disease having Vata and Kapha predominance. But, in fact it is Tridoshaja in origin from Adhoamashaya (Pittasthanasamudbhava).

v Hridradi Avleha (Group A)- has  provided  better  relief  in  most  of  the  symptoms of the disease like Shwasakricchata, Kasa, Nidralpata, Ghurghurakam at highly significant level. Pramoha at significant level. It shows highly significant result in ACQ score.

v Group A has showed highly significant result in objective parameters FEV1% and significant result in PEFR.

v Virechana Karma with Vata-Shleshmahara Dravyas is mentioned in classical texts. Virechana Karma balances all the three Doshas in equilibrium. It removes the unwanted waste material and toxins from the body. It purifies the body and makes it healthier. Samsarjana Karma after Virechana is very necessary because body is not able to digest Guru Ahara, hence Laghu Ahara is advised for 3-7 days according to Shuddhi. After Shodhana Karma the Shamana Aushadi works more effectively.

v Virechana Karma and Haridradi Avleha (Group B):- Group B has provided better relief in most of the symptoms of the disease like Shwasakricchata, Kasa, Pramoha Nidralpata, Ghurghurakam at highly significant level. It shows highly significant result in ACQ score.

v Group B has showed highly significant result in objective parameters FEV1% and in PEFR.

 

v The study has revealed that there was no adverse effect on renal and liver function tests, with which it can be concluded that the drug Haridradi Avleha and procedure Virechana Karma are safe for use in the patients of Tamaka Shwasa (Bronchial Asthma).

v On comparing the effect of two therapies it can be concluded that Group B (Virechana Karma & Haridradi Avleha) provided better relief than Group A (Haridradi Avleha) in most of the sign and symptoms of the disease at significant level.

v Thus it can be concluded that Haridradi Avleha and Virechana Karma can be used as effective and safe therapeutic agents in the management of Tamaka Shwasa (Bronchial Asthma).

  

 

 

 

 


 
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