NEED FOR THE STUDY

Hrud vyasa is a new technical term composed of Hrudaya and Vyasa. ¹ One of  the  Vata prakopa lakshanas is Vyasa, which means asankocha(dilatation). It can happen in any organ or any part of the body, if it happens in Hrudaya it may be considered as Hrud vyasa.

Left ventricular hypertrophy ² is enlargement and thickening of the walls of the left ventricle. LVH is more common in people who have uncontrolled high blood pressure. If it is left untreated leads to high risk of congestive heart failure and irregular heart rhythms,is present in 15% to 20% of the general population.³ It is often prevelant in blacks,the elderly, the obese, and in patient with Hypertension.

Cardio vascular diseases are leading cause of death globally,  17.9 million people died from Cardio vascular disease in 2019, representing 30% of all global deaths. Of these deaths, 85% were due to heart attack and stroke. Inspite of research and development in cardiology, prevention of  LVH in cases of hypertension patients is not satisfactory.Hence there is scope for research in Kayachikitsa and specially Hrudaya Marmaroga. The research question is whether Rasayana chikitsa has a role to play in preventing the development of  LVH in patients of hypertension who are under treatment. A cost effective herbal or herbominerallo mettalic Rasayana is needed in regular practice of preventive ayurvedic cardiology.

Chatushparni is a combination of Shalaparni ⁴, Prishniparni⁵, Mudgaparni⁶, Mashaparni ⁷ with Madhura, tikta, tridosha hara, Hrudya, Balya, Mutrala and Rasayana effects. By vasodilatation, anti-arrythmic activity and maintenance of HDL and lowering LDL effects reduce the load on heart and improve cardiac muscle and vessel nutrition⁸ .

Sarpagandha yoga is a combination of Rasasindura and Sarpagandha. Rasasindura ⁹ acts as Rasayana, sarvavyadhihara, yogavahi, prakrutisthapana, catalyst and target specific action . Sarpagandha ¹⁰ is effective in Bhrama, Shoola, Siragatavata and Anidra   also  proven anti-hypertensive¹¹ drug which helps in reducing afterload thus preventing further hypertrophy. The alkaloid Reserpine is useful in hypertension and cardiovascular diseases¹². Both of the medicines are not explored for there potent cardiotonic activity and there usefulness in preventive cardiology.The shamana yoga will be double blinded in the present study to reduce the bias.

Hence with the alternate hypothesis  a herbal hrudya yoga Chatushparni Rasayana and A Herbo-mineral Yoga Sarpagandha yoga is effective in reducing Hrud Vyasa (Hypertension Induced Left Ventricular Hypertrophy) has been taken with the title

“A DOUBLE BLIND RCT STUDY TO EVALUATE THE EFFICACY OF CHATUSHPARNI RASAYANA AND SARPAGANDHA YOGA IN HRUD VYASA(HYPERTENSION INDUCED LEFT VENTRICULAR HYPERTROPY)”.

Diagnostic Criteria:

ü  Symptoms like Hrutshoola (chest pain),Arohana ayasa (exertional dyspneoa),Pratah shirashoola (early morning headache), Bhrama (Giddiness), Nidra viparyaya(Insomnia), Dourbalya (weakness), Hrudrava (palpitation), Amlodgara (sour belching),Padashopha (pedal oedema), Angamarda (bodyache).

ü  TMT

ü  ECG

ü  2D-ECHOCARDIOGRAPHY - LVH GRADING BY POSTERIOR WALL THICKNESS

-      MILD: 12 to 13mm

-      MODERATE >13 to 17mm

Inclusive criteria:

·       Diagnosed case of HYPERTENSION and LEFT VENTRICULAR HYPERTROPHY on antihypertensive treatment will be taken.

·       Blood pressure-           SBP 150-160mmHg

DBP 90-100mmHg

·       Patients between the age group of 30-65 years.

·       Patients with cornell criteria.

Exclusive criteria:

·       Who doesn’t provide informed consent

·       CCF

·       Multiorgan failure

·       Ejection fraction < 30%

·       Acute M.I

·       Pregnant and lactating women

Interventions:

GROUP-A(20 PATIENTS)

·       Deepana pachana & Kosta shodhana with Haritakyadi yoga 4gms with warm water(b/f) TID for 5 to 7 days  or till samyak shodhana .

·       Chatushparni kashaya bhavita Chatushparni  Rasayana 250mg capsule 2 BD before food for 45 days with Dashamuladi Kashaya anupana (15ml kashaya+60 ml warm water).

GROUP-B (20 PATIENTS)

·       Deepana pachana & kosta shodhana with Haritakyadi yoga 4gms with warm water(b/f) TID for 5 to 7 days  or till samyak shodhana .

·       Sarpagandha kashaya bhavita Sarpagandha yoga 250mg capsule 2 BD before food for 45 days with Dashamuladi Kashaya anupana (15ml kashaya+60ml warm water).

STUDY DESIGN-

ü  PROSPECTIVE DOUBLEBLIND RANDOMIZED CLINICAL TRAIL               

ü   ESTIMATED ENROLLMENT – 40

ü  INTERVENTIONAL MODEL- 2 GROUP ASSIGNMENT

ü  ALLOCATION-RANDOMIZED

ü  MASKING- DOUBLE BLINDED

ü  STUDY DURATION – 55          

ü  FOLLOW UP-AFTER 15 DAYS

Assessment criteria:

The Assessment will be made as per special case record format prepared.

On the basis of 2D-Echocardiography and E.C.G before and at the end of the trial.

Based on both subjective and objective parameters.

Subjective criteria:

Hrutshoola (chest pain),Arohana ayasa (exertional dyspneoa),Pratah shirashoola (early morning headache), Bhrama (Giddiness), Nidra viparyaya(Insomnia), Dourbalya (weakness), Hrudrava (palpitation), Amlodgara (sour belching),Padashopha (pedal oedema), Angamarda (bodyache).