Therapeutic evaluation of Śaliparṇi Kalka Sādhita Kṣīra in the management of Hypertension

Transcription

1 Therapeutic evaluation of Śaliparṇi Kalka Sādhita Kṣīra in the management of Hypertension Preeti Gavali 1 Kishor Gavali 2 Anjali B Prasad 3 Sachin Agrawal 4 A b s t r a c t Hypertension (HTN) is a chronic medical condition in which the blood pressure in the arteries is elevated. It is one of the primary risk factors for heart diseases and stroke, the leading cause of death worldwide and is reported as third ranked factor for disability adjusted life years. There is no definite term given in Āyurveda for hypertension as it is instrumentally diagnosed disease but is indirectly mentioned by various names based on sign and symptoms produced in it. In the present study, 30 Patients of mild and moderate hypertension of Group A were treated with standard control drug Tab. Telmisartan 20mg, once a day and 30 patients of Group B were treated with trial drug Śaliparṇi Kalka Sādhita Kṣīra, 150 ml twice a day. Duration of the trial was 45 days with three follow ups by the interval of 15 days. As a result of both the therapies, group A showed more improvement in lowering down the blood pressure whereas group B showed more relief in associated symptoms and blood investigations which were analysed statistically significant by using Students Paired and Unpaired t test with Welch correction. No adverse effects were observed in any of the treated patients. Key words: Hypertension, Āyurveda, Śaliparṇi 1 Assistant Professor, Dept. of Roga Nidana Evam Vikriti Vigyana, VPAMC, Sangli, 2 Assistant Professor, Dept. of Balroga, R. A. Podar Medical College (Ayu), Worli, Mumbai. 3 Assistant Professor, Agada Tantra Evam Vyavahar Āyurveda, 4 Assistant Professor, Rasashastra Evam Bhaishajya Kalpana, SGCAS & Hospital, Sriganganagar CORRESPONDING AUTHOR Dr. PREETI GAVALI Assistant Professor, Dept. of Roga Nidana Evam Vikriti Vigyana, VPAMC, Sangli E mail: preeti.620@gmail.com 622

2 INTRODUCTION H ypertension is silently killing a large no. of population as it has no any symptom as alarming sign of it in its early stage. That is why it is also called as Silent killer. Overall, approximately 20% of world s adults are estimated to have hypertension, when it is defined as BP in excess of 140/90 mm Hg. The prevalence dramatically increases in patients older than 60 years. In many countries, 50% of individuals in this age group have hypertension. There are at least 970 million people worldwide who have elevated blood pressure (hypertension). In the developed world, about 330 million people have hypertension, as do around 640 million in the developing world. The World Health Organization (WHO) rates hypertension as one of the most important causes of premature death worldwide and the problem is still growing. In 2025, it is estimated that there will be 1.56 billion adults living with high blood pressure. Hypertension is a risk factor for coronary heart disease and the single most important risk factor for stroke. It causes about 50% of ischemic strokes and increases the risk of haemorrhagic stroke. [i] Hypertension deaths in India reached 167,898 or 1.86% of total deaths. The age adjusted Death Rates is per 100,000 of population ranks India 107 in world. [ii] Although the introduction of many hypertensive agents in modern medical science have great importance in the management of hypertension, the hazardous effects of these drugs after long term use are incurable or proves many times fatal, hence an ideal therapy is still obscure. Ayurvedic management of hypertension aims not only to achieve the state of normal blood pressure but also to treat the root cause of disease. Hence, the present study has been under taken with the hope of searching out a better, safer, low economic remedy for the disease by evaluating the therapeutic effects of Śaliparṇi kalka sādhita kṣīra [iii] and comparing it with the effects of allopathic drug Tab. Telmisartan in the management of hypertension. SUBJECTS AND METHODS Aims and objective Therapeutic evaluation of Śaliparṇi kalka sādhita kṣīra in the management of hypertension. Drug review Drug Śaliparṇi kalka sādhita kṣīra (milk decoction with the paste of Desmodium gangeticum) is mentioned in Charaka samhita in context of Hridaya sthita prakupita vāyu (Vitiated Vāyu, one of the three humours, that resides in the heart). Since Vyāna vāyu resides in the Hridaya (heart) which is responsible for the circulation and Hypertension is a circulatory disease, hence the drug is selected to manage hypertension. MATERIALS AND METHODS Patient s selection and Group setting Clinical study was carried out on 60 clinically diagnosed patients of mild and moderate hypertension, selected randomly from OPD/IPD of Arogyashala, N.I.A., Jaipur and were categorized into two groups. 30 Patients of Group A were treated with control drug Telmisartan 20mg, once a day under the guidance of Modern Consultant and 30 patients of Group B were treated with Trial drug Śaliparṇi Kalka Sādhita Kṣīra, 150 ml, twice a day. Duration of the trial was 45 days with three follow ups by the interval of 15 days. Results before treatment and after treatment was compared and analyzed statistically by using Students Paired and Unpaired t test with Welch correction. Preparation of Trial drug Cūrṇa (powder), being the Upakalpana of kalka (substitute of paste) [iv], Śaliparṇi yavkut cūrṇa (rough powder) was given to the patients to prepare the Śaliparṇi kalka sādhita kṣīra. For its preparation, all the patients were instructed to boil 10 gm of Śaliparṇi powder with 150 ml water & 150 ml milk on mild flame without covering its mouth. Water is allowed to evaporate slowly till the quantity of the liquid is reduced to half of initial volume and then was advised to filter and drink it. [v] Selection criteria All the patients were selected with the following criteria Inclusion Criteria Patients between the age group of 18 to 70 years of either gender presenting with given symptoms of hypertension and having elevated blood pressure i.e. above 140/90 mm of Hg, were selected for the trial. Exclusion Criteria Patients below 18 years and above 70 years of age, Patients having hypertension more than 180/ 110 mm of Hg, Patients having hypertensive retinopathy, Patients labelled as malignant hypertensive, Patients having serious illness/complications of cardiovascular system, cerebro vascular system, renal system & diabetes mellitus, Patients having severe hepatic impairment, biliary obstructive disorders, pregnancy and lactation were excluded for the trial.

3 Diagnostic criteria Diagnosis of hypertension is mainly objective based on elevated level of sphygmomanometric reading in which only mild or moderate cases of hypertension were taken. 1) Clinical Classification of Hypertension as per WHO/International Society of Hypertension (ISH) Special Report,1995 [vi] which is given in table no. 1. 2) Subjective Parameters Śirahśūla (headache), Bhrama (vertigo), Raktang akshita (redness of eyes), Krodh prachurata (loss of patience), Klama (fatigue), Kampa (tremors), Dourbalya (weakness), Anidra (insomnia / disturbed sleep), Hritdrava (palpitations), Smritināśa (impaired memory), Śvāsakracca (dyspnoea), Niśāmūtrata (nocturia), Bahumūrata (polyurea). 3) Lab Investigations done for the Study All the blood examinations including RBS, SGOT, SGPT, B. Urea, S. Creatinine and Lipid profile, urine examinations and E.C.G. were conducted two times i.e. before and after treatment, in each patient of both the groups. Assessment of the disease Assessment of the blood pressure was done by measuring it with the help of its measuring device, sphygmomanometer and was observed after each follow up for its measurement. Clinical improvement in the BP and lab parameters was assessed by observing the percentage relief in them whereas clinical assessment in the symptoms and their severity was objectively done in terms of their gradation. The relative extent of all these criteria was recorded according to the rating scale in each patient at the initial stage and subsequent follow ups. Assessment of Results Assessment Criteria for effect of treatment on blood pressure To calculate the percentage relief in blood pressure, mean BP of patients of both the times, i.e. before treatment and after treatment, of each group was observed and percentage relief was calculated at the end by using the below given formula; Assessment Criteria for effect of treatment on symptoms To calculate the % relief on each symptom, mean of each symptom of patients of both the times, i.e. before treatment and after treatment, of each group was observed and percentage relief was calculated at the end by using the below given formula; Mean of each symptom (BT) Mean of each symptom (AT) x 100 Mean of each symptom (BT) (Here, mean of each symptom is indicative of the mean of each grading given for its assessment) Overall assessment of therapy on symptoms Overall effect of the therapy was assessed in terms of complete remission, marked improvement, moderate improvement, mild improvement and no improvement by adopting the following criteria. Complete remission: 100% relief was considered as complete remission. Marked improvement: 75% to 99% relief was taken as marked improvement. Moderate improvement: 50% to 74% improvement was recorded as moderate improvement. Mild Improvement: 25% to 49% improvement was considered as improvement. No Improvement: less than 25% reduction was noted as unchanged. Statistical Tests used: Students Paired t test was used to see the intra group effects and Unpaired t test with Welch correction was used for inter group comparison of the effect of therapies. OBSERVATIONS All the observations found in the study are shown by the graph presentation from graph no. 1 to graph no. 10. Graph no. 1: Showing age wise distribution of patients AGE WISE DISTRIBUTION Percentage relief in Systolic Blood Pressure = Mean of BP (BT) Mean of BP (AT) x 100 Mean of BP (BT) Percentage relief in Diastolic Blood Pressure = Mean of BP (BT) Mean of BP (AT) x 100 Mean of BP (BT) % % % % %

4 Graph no. 2: Showing sex wise distribution of patients SEX WISE DISTRIBUTION Female 52% Male 48% Graph no. 6: Distribution showing onset of the disease in patients Gradual 45% ONSET WISE DISTRIBUTION Sudden 55% Graph no. 3: Showing religion wise distribution of patients RELIGION WISE DISTRIBUTION Muslim 18% Sikh 2% Hindu 80% Graph no. 7: Showing family history wise distribution of patients FAMILY HISTORY WISE DISTRIBUTION Unknown 17% Absent 50% Present 33% Graph no. 4: Showing occupation wise distribution of patients OCCUPATION WISE DISTRIBUTION Unemploy ed 15% Housewife 40% Service 27% Business 18% Graph no. 8: Showing nature of work wise distribution of patients DISTRIBUTION ACCORDING TO NATURE OF WORK Mixed 40% Ambulatory 10% Sitting 32% Sedentary 15% Standing 3% Graph no. 5: Showing socio economic status wise distribution of patients Graph no. 9: Distribution showing mental stress in patients SOCIO-ECONOMIC STATUS WISE DISTRIBUTION MENTAL STRESS OF PATIENTS Lower 23% Middle 52% Higher 25% Absent 15% Occupational 12% Economical 23% Personal 7% Familial 43%

5 Graph no. 10: Showing BMI wise distribution of patients BMI WISE DISTRIBUTION OF PATIENTS Overweigh t 38% Obese 8% Normal 54% RESULTS All the results obtained in the study, on Blood Pressure, on associated symptoms and on lab. Investigations, are shown by the given table and graph presentation. Table no. 2 to 6 and graph no. 11 to 15 are showing all the results obtained. Table no. 1: Showing Clinical Classification of Hypertension as per WHO/International Society of Hypertension (ISH) Special Report, Sl. No. Category Systolic BP (in mmhg) Diastolic BP (in mmhg) 1. Normal <130 mmhg <85 mmhg 2. High normal mmhg mmhg 3. Stage I (mild HTN) mmhg mmhg 4. Stage II (Moderate HTN) mmhg mmhg 5. Stage III (Severe HTN) mmhg mmhg 6. Stage IV (Very severe HTN) > 210 mmhg >120 mmhg 7. Malignant Hypertension (HTN) > 200 mmhg > 140 mmhg Table no. 2: Results on B.P. and associated symptoms of both groups Parameter Systolic B.P Diastolic B.P Sirahshula Bhrama Rāga Raktangakshita Krodha prachurata Klama Kampa Daurbalya Anidra Hritdrava Smritināśa Group Mean(n=30) % B.T. A.T. Diff. Change S.D S.E t Value p A < ES B < ES A ES B < ES A < ES B < ES A < ES B < ES A NS B NS A S B S A < ES B < ES A NS B < ES A < ES B ES A S B < ES A < ES B < ES A < ES B < ES A NS B NS Śvāsakracca A < ES Result

6 Nishamutrata B < ES A VS B VS Bahumutrata A NS B VS Table no. 3: Inter group comparison on B.P. and associated symptoms Parameter Groups Mean Diff (n=30) t p Systolic B.P A B NS Diastolic B.P A B NS Sirahshula A B NS Bhrama A B NS Rāga A B VS Raktangakshita A B NS Krodha prachurata A B VS Klama A B S Kampa A B NS Daurbalya A B < ES Anidra A B < ES Hritdrava A B ES Smritināśa A B < ES Śvāsakracca A B S Nishamutrata A B NS Bahumutrata A B NS Result Table no. 4: Showing Overall effect of therapy on symptoms RESULT GROUP A % GROUP B % Complete remission 00 00% 00 00% Marked improvement 00 00% 00 00% Moderate improvement 00 00% % Mild improvement 15 50% % No improvement 15 50% % Table no. 5: Results on Lab. investigations TESTS RBS SGOT SGPT B. Urea Sr. Creatinine Group Mean(n=30) % B.T. A.T. Diff Change S.D S.E t p A NS B NS A NS B NS A NS B NS A NS B NS A NS B NS Result T. Cholesterol A ES

7 Sr. Triglycerides HDL LDL B < ES A NS B ES A VS B S A NS B NS VLDL A NS B NS Table no. 6: Inter Group Comparison on Lab. investigations Tests Groups Mean Diff (n=30) t p RBS A B NS SGOT A B VS SGPT A B NS B. Urea A B NS Sr. Creatinine A B NS T. Cholesterol A B S Sr. Triglycerides A B NS HDL A B NS LDL A B NS VLDL A B NS Result Graph No. 11: Showing result of both the therapies on Blood Pressure 14.00% RESULT ON B.P 12.00% 10.00% 8.00% 6.00% 4.00% 2.00% 0.00% Systolic B.P Diastolic B.P GroupA 11.66% 12.57% GroupB 8.86% 7.63%

8 Graph No. 12: Showing result of both the therapies on associated symptoms RESULT ON ASSOCIATED SYMPTOMS 60.00% 50.00% 40.00% 30.00% 20.00% 10.00% 0.00% Sirahshula Bhrama Raga Raktangaks hita Krodha prachurata Klama Kampa GroupA 44.58% 56.23% 24.81% 37.52% 33.33% 2.30% 39.34% GroupB 42.20% 55.56% 0% 35.84% 35.17% 42.86% 40.67% Graph No. 13: Showing result of both the therapies on associated symptoms 60.00% 50.00% 40.00% 30.00% 20.00% 10.00% 0.00% RESULT ON ASSOCIATED SYMPTOMS Daurbalya Anidra Hritdrava Smritinash Shwaskritch ata Nishamutrat a Bahumutrat a GroupA 7.26% 29.50% 33.33% 1.41% 26.52% 20.94% 2.68% GroupB 38.58% 45.40% 48.08% 1.94% 35.85% 27.27% 18.20%

9 Graph No. 14: Showing overall effect of therapies on associated symptoms OVERALL EFFECT OF THERAPY ON SYMPTOMS 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Marked improvement Moderate improvement Mild improvement No improvement Group A 0% 0% 50% 50% Group B 0% 0% 76.60% 16.70% Graph No. 15: Showing result of therapies on lab. Investigations 12.00% RESULT ON LAB. INVESTIGATIONS 10.00% 8.00% 6.00% 4.00% 2.00% 0.00% RBS SGOT SGPT B.Urea Sr. Creatini ne Sr. choleste rol Sr.Trigly cerides HDL LDL VLDL GROUP A 10.14% 0.77% 0.97% 0.63% 1.46% 3.62% 1.93% 2.84% 4.60% 10% GROUP B 4.23% 3.05% 2.89% 3.63% 7.93% 4.80% 5.39% 4.98% 0.00% 5.65%

10 DISCUSSION Discussion regarding probable modes of action of Trial drug Śaliparṇi kalka sādhita kṣīra on symptoms produce in hypertension. Śaliparṇi is said to be tridoṣa śāmaka (which pacifies all three doṣa) and kṣīra (milk) is Vāta, Pitta and Rakta śāmaka. Also, the drug is having rakta vikārahara (pacifies diseases by infected blood) and sonita sthapana (blood stability) properties which might have the reason of its effect on śirahśūla, rāga and raktang akshita as rakta is predominantly involved in all these features. It might have relieved in kampa due to its property of nādibalya (nervine tonic). The trial drug possess rasāyana (immuno modulating) property by which it helps in relieving stress, anxiety giving stability to mind which might be the reason of getting relief by it in anidra and krodha prachurata. Being a rasāyana and also by the effect of kṣīra which is said to be buddhi prabhodaka (memory booster), it might have improved in smritināśa up to some extent. The drug also possesses the property of hridya and balya (cardiac and nervine tonic), that s why it might have relieved in the symptoms hritdrava and śvāsakracca. The drug is having dīpana property which helps to alleviate obstruction in the strotas (micro channels) due to Āma (undigested food) by its digestion and thereby resulting into strotośodhana (purification of micro channels) and vātanulomana (clearance of passage). This might have the reason of its action in getting relief in klama. It also acts as a nervine tonic, antioxidant and immune modulator through its rasāyana property. By this property, it normalizes the process of Dhātu (tissue) formation producing the prashasta dhātu (normal tissues) and purifies vitiated dhātu. It is also having the property of balya and it is also said to be used in daurbalya (weakness) as its rogaghnata (disease pacifying property). That s why it must have helped in getting relief in daurbalya. Rasāyana drugs also possess the property of strotośodhana which makes them useful where the samprāpti (chain of disease producing series) of disease is due to āvaraṇa (obstruction) i.e. due to mārgāvarodha (obstruction of passage), as the same happens in hypertension. heart. Through its pācana, mūtrala (diuretic), vātanulomana properties, it relieved srotorodha (obstruction of micro channels), does digestion of āma and also decreases blood volume which might have contributed to decrease blood pressure. CONCLUSION The study reveals that Śaliparṇi kalka sādhita kṣīra is found to be more effective in regression of associated symptomatology and blood investigations, especially cholesterol level, which was statistically significant but it was judged to be less effective in reducing the blood pressure as compared to the control drug Tab. Telmisartan. As in this study, direct relationship is found between dietary, habitual & psychological factors and occurrence of this disease, so it is suggested that along with the use of this medication, use of Āchara Rasāyana (life style management), which is a moral code of conduct, should also be stressed. From the results obtained in Group A and B, it can be concluded that therapy Śaliparṇi kalka sādhita kṣīra is a safe and effective Ayurvedic treatment modality in the management of mild and moderate ranges of essential hypertension. **** Discussion Regarding Probable modes of action of Trial drug on Blood Pressure and cholesterol level It can be said that the significant result produced by Śaliparṇi kalka sādhita kṣīra in hypertension is may be due to its rasāyana and balya effect thereby producing anxiolytic, anti-stress, CNS depressant effect by inhibiting noradrenergic sympathetic nerves supplying to the

11 REFERENCES i. ii. -WHO data published in April iii. Pt. Kashinath Shashtri and Dr. Gorakha Nath Chaturvedi, Charak Samhita, Part-II, Reprint 2004, Chaukhamba Bharti Academy, Varanasi, Chikitsa sthana 28/96, pp iv. Prof. K. R. Srikantha murthy, Ashtanga samgraha of Vagbhatta, Vol. II, 1 st edition -1996, Chaukhamba orientalia Varanasi, Kalpa sthana, Ch 8/10, pp 618. v. Yadavji trikamji Acharya. Dravya guna Vignana, 2 nd ed. Mumbai: vi. Satyabhamabaipanduranga nirnayasagaramudrana yantralaya; Uttarardha paribhasha khanda. p vii. Harsh Mohan, Textbook of Pathology, 4 th edition; Jaypee Brothers Medical Publishers, pp 670. Source of Support: Nil. Conflict of Interest: None declared How to cite this article: Preeti et al. : Therapeutic evaluation of Śaliparṇi Kalka Sādhita Kṣīra in the management of Hypertension. AAMJ 2016; 2: ΛΛΛΛ