Therapeutic efficacy of Shirishavaleha prepared by Water and Kanji as liquid media and its effect on Tamaka Shwasa (Bronchial Asthma) Scholar Harmeet Kaur PhD Scholar Department of Rasa Shastra and Bhaishajya Kalpana including Drug Research Institute for Post Graduate Teaching & Research in Ayurveda Gujarat Ayurved University, Jamnagar 1
Non-communicable diseases are now the most common cause of death world wide We have highest incidence of DM, CAD, HTN and Bronchial Asthma as compared to rest of the world. 2
Global Burden of Asthma Asthma is the most common chronic diseases in the world. It is estimated that around 300 million people in the world currently have asthma. The rate of asthma increases as communities adopt western lifestyles and become urbanized. 3
Selection of Drug Shirishavaleha* * Yadav S, Galib R, Prajapati PK. Shirishavaleha- Promising remedy in bronchial asthma. International journal of pharmacy and Life Sciences. Dec 2011; 2(12): 1309-1314. 4
Importance of present study Seers used dravas like Kshira, Go-mutra, Takra and Kanji etc. in preparation of different formulations based on the necessity. Kanji, being a media of Amla Pradhana is expected to liquefy (Kledayati), disintegrate (Jarayati) and facilitate extraction of more principles (Apakarshayati) from the raw material. Drugs with Vatakaphahara and Vatanulomna are beneficial in case of Tamaka Shwasa. Kanji possess these qualities. 5
In the present study, it was planned to prepare Shirishavaleha in presence of Kanji as liquid media and compare the efficacy of the same with Shirishavaleha prepared in presence of Water. 6
Formulation Composition Ingredients Quantity In grams Formulation (g) 1 Shirisha 50 Pala 2400 1200 2 Pippali 1 Pala 48 24 3 Priyangu 1 Pala 48 24 4 Kushtha 1 Pala 48 24 5 Ela 1 Pala 48 24 6 Nilini 1 Pala 48 24 7 Haridra 1 Pala 48 24 8 Daruharidra 1 Pala 48 24 9 Shunthi 1 Pala 48 24 10 Nagakesara 1 Pala 48 24 11 Guda 200 Pala 9600 5000 g Drugs were procured from Pharmacy, GAU and authenticated at Pharmacognosy Laboratory, I.P.G.T. & R.A, Jamnagar. Both trial drugs were prepared in the Department of RS&BK, IPGT and RA, Jamnagar by following classical guidelines. 7
Aims and Objectives To assess comparative effect of both trial drugs in cases of Tamaka Shwasa (Bronchial asthma) IEC No. CTRI No. PGT/7-A/Ethics/2013-2014/1767 CTRI-2013/10/004083 8
Materials and Methods 66 Patients having signs and symptoms of Tamaka Shwasa as described in Ayurvedic classics were selected from OPD and IPD of IPGT & RA, GAU, Jamnagar. Detailed history was taken and physical examination was done following the guidelines specified in the pro forma. Study was a Randomized Double Blind Study. 9
Registration of Patients Group No. of patients Registered Completed Drop-out Group-A 31 30 01 Group-B 35 33 02 Total 66 63 03 Reason for dropped out: All the three left the city based on their job requirements. 10
Inclusion Criteria Patients with classical signs and symptoms of Tamaka Shwasa Age 16-60 years. Mild persistent cases of Bronchial Asthma with daytime symptoms 3-6 / week and nocturnal symptoms with 3-4 / month Moderate persistence cases with daytime symptoms daily and nocturnal symptoms with one or more than one week but not more than 2 weeks. Exclusion Criteria Age >60 and < 16 years. Dyspnoea resulting from cardiac origin, anemia, tuberculosis, malignancy and other chronic debilitating diseases. Patients having classical symptoms of Maha, Urdhva, Chhinna and Kshudra Shwasa. HIV positive cases. Pregnant / Lactating Mothers. Patients who need inhalers daily 11
Grouping Selected patients were randomly divided into two groups with the help of computer generated random sequence.* Posology Group A : SW Group B : SK Dose : 10 g twice daily before food Anupana : Luke- warm water orally Duration : 28 days (4weeks) Follow-up : 14 days (2 weeks) * Randomization Plan from http://www.randomization.com, seed 29516, created on 28 October 2013, 1:50:59 12 PM, 80 patients randomized into two blocks.
Investigations Routine Hematological Biochemical Urine TLC, DLC, Hb, ESR, AEC F.B.S., S.G.O.T, S.G.P.T. Alkaline Phosphates, etc. PEFR (Peak Expiratory Flow Rate) Specific BHT (Breath Holding Time) Chest X-ray (if required) 13
Study intervention Modern medicine was allowed SOS in patients who felt acute breathlessness in both groups during the period of treatment by referring them to a modern doctor. 14
Criteria for Assessment Subjective Criteria: Improvement in signs and symptoms Asthma Control Questionnaire (ACQ) before and after treatment. Objective criteria: RR, BHT, PEFR, AEC etc. before and after treatment. Statistical tests t - test was applied to evaluate clinical significance of the therapy in between the groups. 15
Results in Cardinal Symptoms % 80 70 60 50 40 30 20 10 0 72.97 75.21 75.97 75.75 83.95 85.12 80.44 78.26 71.69 Group A 90 n = 63 74.39 Group B 59.7 61.53 16
% 120 100 80 60 40 89.83 88.61 80.31 90.17 82.15 77.37 98.04 98.48 n =63 Group A Group B 20 0 Relief after expectoration Peenasa Catch on phonation need of emergency drug 17
Results in Objective Parameters % 100 80 60 40 20 0-20 -40-60 -80-100 n= 63 71.11 83.33 60.57 71.26 BHT RR PEFR AEC -18.46-38.79-79.98-73.94 Group A Group B
Effect on ACQ % 63 62 62.65 n = 63 61 60 59 59.06 Group A Group B 58 57 ACQ 19
Overall effect of Therapy % 90 80 70 60 50 40 30 20 10 0 0 0 Complete remission (100%) 73.33 78.78 Marked improvement (76-99%) 26.66 21.12 Moderate improvement (51-75%) 0 0 0 0 Mild improvement (26-50%) Unchanged( <25%) Group A 0 73.33 26.66 0 0 Group B 0 78.78 21.12 0 0 n = 63 20
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Discussion About 84.85% patients were allergic to dust. Allergic factors affect the respiratory system by their direct contact. Allergic inflammation is influenced by all such factors, constricting the airway smooth muscles, expressing symptoms of asthma.* Vata-Kapha Prakriti was found in 80.30% of patients. It can be inferred Tamaka Shwasa precipitates in individuals of Vata- Kapha prakriti as the disease also a Vata-Kaphaja in origin. * http://www.jacionline.org/article/s0091-6749(05)00426-4/abstract 22
Contd. Recurrence of the symptoms was observed in four patients (13.33% in Group-A and 12.12% Group B) in each group; those required use of relieving drugs. Most of the patients during their follow-up period didn t felt the need of any emergency medication. Feeling of betterness was reported by many indicating improved Quality of Life. 23
Probable mode of action The formulation Shirishavaleha is found to be predominant with Tikta Kashaya, Madhura Rasa, Ushna Virya, Katu Vipaka and Kapha Vata / Tridosha Shamaka qualities. These ingredients also possess Vatanulomana, Agni Dipana, Kaphanissarana, Swasahara, Shothahara, Vishaghna properties. All these qualities in combination will became a perfect blend in the form of Shirishavaleha beneficial in pathological conditions where Vata Kapha are predominant like that of Tamaka Shwasa. 24
Conclusion Looking into the observations and the media used in the preparation of Shirishavaleha; it can be concluded that Kanji is more beneficial against water as media. Both forms of Shirishavaleha are efficacious in cases of Tamaka Shwasa and can be good alternatives for contemporary medicines. Both trial drugs are effective without manifesting any adverse reactions and hence are safe.
Acknowledgement RS & BK Family Audience
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