Hypertensive heart diseaseHypertension induced left ventricular hypertrophy

Not yet recruiting

• Conditions: Hypertensive heart disease withoutheart failure. Ayurveda Condition: HRUDVYASA, (2) ICD-10 Condition: I119||Hypertensive heart disease withoutheart failure. Ayurveda Condition: Hrudvyasa,

• Registration Number: CTRI/2022/09/045207
• Lead Sponsor: Taranath Government Ayurvedic Medical College And HospitalBallari

Brief Summary

**NEED FOR THE STUDY**

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

Leftventricular hypertrophy 2 is enlargement and thickening of the wallsof the left ventricle. LVH is more common in people who have uncontrolled highblood pressure. If it is left untreated leads to high risk of congestive heartfailure and irregular heart rhythms,is present in 15% to 20% of the generalpopulation.3 It is often prevelant in blacks,the elderly, the obese,and in patient with Hypertension.

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

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

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

Hencewith the alternate hypothesis  a herbal hrudyayoga Chatushparni Rasayana and A Herbo-mineral Yoga Sarpagandha yoga iseffective in reducing Hrud Vyasa (Hypertension Induced Left VentricularHypertrophy) has been taken with the title

**“A DOUBLE BLIND RCT STUDY TO EVALUATE THE EFFICACY OFCHATUSHPARNI RASAYANA AND SARPAGANDHA YOGA IN HRUD VYASA(HYPERTENSION INDUCEDLEFT VENTRICULAR HYPERTROPY)â€.**

**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 LEFTVENTRICULAR HYPERTROPHY on antihypertensive treatment will be taken.

·      Blood pressure-           SBP150-160mmHg

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

·      Chatushparni kashaya bhavita Chatushparni  Rasayana 250mg capsule 2 BD before food for45 days with Dashamuladi Kashaya anupana (15ml kashaya+60 ml warm water).

**GROUP-B (20 PATIENTS)**

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

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

**STUDYDESIGN-**

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 perspecial case record format prepared.

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

Based on both subjective andobjective parameters.

**Subjective criteria:**

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

  

| | | | |

| --- | --- | --- | --- |

|**SI.NO**

**SYMPTOMS**

**SEVERITY**

**GRADE**

|**1.**

Hrutshoola (chest pain)

 Â·       No hrutshoola

·       1 or less than once a week, relieves without any intervention

·       2-3 times a week, relieves after mild rest

·       More than 3 times a week, needs medical intervention

·       Persistent

CS

 CD1

 CD2

 CD3

CD4

 

|**2.**

Arohana ayasa (exertional dyspneoa)

 Â·       No arohana ayasa

·       Occurs once a week relieves without any intervention

·       2-3 times a week but does not affect daily routine relieves after rest

·       More than 3 times a week relieves after medical intervention

·       Persistent, no relief at all.

CS

 CD1

 CD2

 CD3

CD4

 

|**3.**

PratahShirahshoola (early morning headache)

 Â·       No Pratah shirashoola

·       Occurs once a week relieves without any intervention

·       2-3 times a week but does not affect daily routine relieves after rest

·       More than 3 times a week relieves after medical intervention

·       Persistent, no relief at all.

CS

 CD1

 CD2

 CD3

CD4

 

|**4.**

Bhrama (giddiness)

 Â·       No bhrama

·       Bhrama occurs once a week relieves without any intervention

·       2-3 times a week but does not affect daily routine relieves after rest

·       More than 3 times a week relieves after medical intervention

·       Persistent, no relief at all.

CS

CD1

 CD2

 CD3

 CD4

 

|**5.**

Nidraviparyaya

 Â·       No nidra viparyaya

·       Once a week, regains sleep,total sleep – 6-8 hours.

·       2-3 times a week,regains sleep after longer time total sleep-less than 6hours.

·       More than 3 times a week total sleep < 4hours

·       Daily, sleep hours<3 hours

 CS

CD1

 CD2

  CD3

 CD4

 

|**6.**

Dourbalya (weakness)

 Â·       No dourbalya

·       Dourbalya occurs once a week relieves without any intervention

·       2-3 times a week but does not affect daily routine relieves after rest

·       More than 3 times a week relieves after medical intervention

·       Persistent, no relief at all.

CS

CD1

 CD2

 CD3

 CD4

 

|**7.**

Hrudrava (palpitation)

·       No hrudrava

·       Palpitation after heavy physical excercise, subsides with rest does not affect daily routine

·       Palpitations without any physical activity, occurs 1-2 times a week, subsides without medications

·       Palpitations more than 3 times a week, patient on medications

·       Persistent palpitations, no relief with medications.

CS

 CD1

  CD2

  CD3

 CD4

|**8.**

Amlodgara(sour belching)

 Â·       No belching

·       Feeling of belching with no sound

·       Feeling of belching with mild sound

·       Feeling of belching with moderate sound

·       Feeling of belching with severe sound

CS

CD1

CD2

CD3

CD4

 

|**9.**

Padashopha (pedal oedema)

 Â·       No pada shotha

·       1 or less than once a week, subsides without any intervention

·       2-3 times a week, subsides after limb elevation, rest etc.

·       More than 3 times a week needs medical intervention

·       Persistent

CS

 CD1

 CD2

CD3

 CD4

 

|**10.**

Angamarda (Bodyache)

 Â·       No angamarda

·       1 or less than once, does not affect daily routine

·       2-3 times a week, relieves after taking rest.

·       More than 3 times a week relieves after taking analgesics

·       Persistent, repeated body aches

CS

 CD1

 CD2

 CD3

CD4

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-08-30
• Study Start: 2022-10-09

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1.Diagnosed case of HYPERTENSION and LEFT VENTRICULAR HYPERTROPHY on antihypertensive treatment will be taken.
• 2.Blood pressure-SBP 150-160mmHg DBP 90-100mmHg 3.Patients between the age group of 30-65 years.
• 4.Patients with cornell criteria.

Exclusion Criteria

1.CCF 2.Multiorgan failure 3.Ejection fraction < 30% 4.Acute M.I 5.Pregnant and lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in Hypertension	8 Weeks

Secondary Outcome Measures

Name	Time	Method
Improvement in Left ventricular hypertrophy	09 weeks

Trial Locations

Locations (1)

Taranath Government ayurvedic Medical College And Hospital,Ballari; 🇮🇳 Bellary, KARNATAKA, India

Taranath Government ayurvedic Medical College And Hospital,Ballari

🇮🇳Bellary, KARNATAKA, India

Dr Kanchana Sharagar

Principal investigator

9686707603

kanchusharagar123@gmail.com