跳至主要内容
临床试验/CTRI/2024/05/067265
CTRI/2024/05/067265尚未招募3 期

A Randomised controlled trail to evaluate the efficacy of Ayurveda Intervention (Nitya Virechana)as an add-on to Standard Care in Secondary Hyperlipidemia.

Nandini RD1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月26日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Reduction in Cholesterol levels

研究概览

简要总结

RAJIV GANDHI UNIVESITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

COMPLETED PERFORMA FOR REGISTRATION OF SUBJECT (PANCHAKARMA) FOR THE DISSERTATION M.D. (AYURVEDA)

A RANDOMISED CONTROLLED TRAIL TO EVALUATE THE EFFICACY OF AYURVEDA INTERVENTION (NITYA VIRECHANA) AS AN ADD-ON TO STANDARD CARE IN SECONDARY HYPERLIPIDEMIA.

bY

dr. NANDINI R D

1st year pg SCHOLAR

DEPT. OF PANCHAKARMA

AYURVEDA MAHAVIDYALAYA, HUBLI-580024

GUIDE

Dr. PADMAVATI VENKATESH

M. D (Ayu),PROFESSOR

PG DEPT. OF PANCHAKARMA

AYURVEDA MAHAVIDYALAYA, HUBLI – 580024

CO-GUIDE

DR. RAMACHANDRA LATTI

M.B.B.S M.D.

RTD PROFESSOR

DEPT. OF PHYSIOLOGY

PIMS RURAL MEDICAL COLLEGE

LONI, MAHARASTRA STATE

2022-2023

AYURVEDA MAHAVIDHYALAYA

HUBLI – 580024

From,

DR. NANDINI R D

PRELIMINARY M.D (Ayu) SCHOLAR

DEPARTMENT OF PANCHAKARMA

AYURVEDA MAHAVIDYALAYA, HUBLI.

To,

THE REGISTRAR

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA.

 Through,

THE PRINCIPAL AND

HEAD OF THE DEPT,

DEPARTMENT OF PANCHAKARMA

AYURVEDA MAHAVIDYALAYA, HUBLI – 580024

 Respected Sir,

Sub: Submission of completed proforma for registration of subject for dissertation

I would request you to kindly register the below mentioned subject which has been reviewed and clarified, against my name for the submission of the dissertation to the Rajiv Gandhi University of Health Sciences, Bangalore, for the partial fulfilment of M.D (Ayu) in Panchakarma.

 Title of Dissertation:

A RANDOMISED CONTROLLED TRAIL TO EVALUATE THE EFFICACY OF AYURVEDA INTERVENTION (NITYA VIRECHANA) AS AN ADD-ON TO STANDARD CARE IN SECONDARY HYPERLIPIDEMIA. Here with, I am enclosing the completed proforma for the registration of subject of dissertation.

Thanking You

 Place**:** HubliYours Faithfully

 Date: 28/10/2023                    **(**Dr. NANDINI R D)

RajIv Gandhi University Of Health SciEnces

BANGALORE, KARNATAKA

ANNEXURE – II

PROFORMA****for registration of subject for dissertation

NAME OF THE CANDIDATE AND ADDRESS

:

DR. NANDINI R D

1ST YEAR PG SCHOLAR

AYURVEDA MAHAVIDYALAYA

HEGGERI EXTENSION

OLD HUBLI, HUBLI 580024.

  |PERMANENT ADDRESS

:

25 VINAYAK BUILDING NEAR MANIKESHWARI TEMPLE GDA LAYOUT J.R NAGAR KALABURGI 585101

  | NAME OF THE INSTITUTION

:

AYURVEDA MAHAVIDYALAYA, HUBLI

COURSE OF STUDYING

:

DOCTOR OF MEDICINE                                                    IN PANCHAKARMA (AYURVEDA)

DATE OF ADMISSION OF COURSE

:

18/04/2023

TITLE OF THE TOPIC

:

A RANDOMISED CONTROLLED TRAIL TO EVALUATE THE EFFICACY OF AYURVEDA INTERVENTION (NITYA VIRECHANA) AS AN ADD-ON TO STANDARD CARE IN SECONDARY HYPERLIPIDEMIA.

6.   BRIEF RESUME OF INTENDED WORK:

6.1 NEED FOR THE STUDY:

Sedentary life style, stress, untimely and disturbed sleep patterns, various addictions, unhealthy dietetic deviations contribute vital role in the manifestation of lifestyle disorders. The enlisted factors impair metabolic activities at GIT level as well as cellular level making one prone to series of disorders. Hyperlipidaemia is one such disorder identified as a potential risk factor for multitudes of diseases like metabolic syndrome, hypertension, stroke, cardiovascular diseases.Hyperlipidaemia is one of the burning issue in today’s era. Hyperlipidaemia is classified as familial also known as primary hyperlipidaemia caused by specific genetic abnormalities and acquired also known as secondary hyperlipidaemia resulting from another underlying disorder that leads to alterations in plasma lipid and lipoprotein metabolism.1

Secondary Hyperlipidaemia is lipoprotein metabolic disorder with abnormal elevated levels of cholesterol, cholesterol esters, and triglycerides in plasma.2Lipid and lipoprotein deviations are extremely common in general population and are regarded as modifiable risk factors for Cardiovascular Disease due to their influence on Atherosclerosis.3

NCEP (National Cholesterol Education Programme) ATP III guidelines III of united states recommended cholesterol levels less than 200mg/dl whereas values exceeding 240mg/dl are considered as high-risk factor.Raised cholesterol (>220mg/dl) is prevalent in 60% population of India, whereas in males it is prevalent in 45% individuals and 15% in females. HDL reported values 28.2% in males and 12.9% females have HDL below1mmol/L.4

Secondary Hyperlipidaemia is relatively asymptomatic condition as far as patient undergoes investigations or reported ischemic changes hence termed as silent killer. Secondary Hyperlipidaemia is the foundation of multiple metabolic disorders including various fatal conditions like IHD, Stroke, and CCF (Congestive Cardiac Failure) etc. To combat this and to break the chain sincere efforts and extensive experimental studies are going on. In 2018 lipid-lowering guidelines came out with suggestion of administration of new lipid-lowering drugs. But most of these modern drugs are potentially toxic, costly and are contraindicated in hepatic or renal impairment, gall bladder diseases and during pregnancy5. Diagnosed Secondary Hyperlipidaemia individuals try their level best by adopting various types of fasting, fat free diet, supplement of lipids and exercises before approaching hospitals. In-spite of multiple sincere efforts fail to lower raised cholesterol levels significantly makes patients to get frustrated. Here, Ayurveda can intervene by modification of risk factors and prevention of undue complications.

Direct clinical reference is not available in Ayurveda classics correlating to Hyperlipidaemia. There are scattered references available in Ayurveda which can nearly be co-related to Raised ‘Medas’ in Rasayani upto certain extent. As per Ayurveda, Medo Dhatu, Vasa andMajja Dhatu possess similarity of Snehatwa and so lipids metabolism can be correlated with the above said Dhatu vyapar. Attempts are being made to co-relate this condition clinically to ‘Raktagatsneha Vriddhi’, ‘Rasaraktagat-sneha Vriddhi’, Medovriddhi, ‘Medoroga’, ‘Sthaulya’ etc by various scholars of Ayurveda.

Hyperlipidaemia is Santarpanajanya bahudosha Medo Dhatupradoshajacondition. Repeated ingestion of excessive Kapha and Meda vruddhikar factors hamper Prathama  Avasthapaka to make partial digestion of Annarasa. Quantitative increase and functional impairment of Kapha Dosha results in lack of perfect end product of fat metabolism that tends to remain in blood vessels. This Amatwa at Medovaha Srotas plays significant role in initial pathophysiology. The qualities are comparable- the raised lipids can be linked to Sneha,  Baddhaand/ or Abaddha  Medas along with  Sama Rasa embedded in Rasayani.

Hyperlipidaemia is Bahudosha avasta caused due to altered functioning of thermochemical energy considered as Agni. This study is intended to treat Hyperlipidaemia through new interventional concept of Nitya Virechana to eliminate Bahudosha in small quantity on daily basis. Drugs selected for Nitya Virechana mainly possess Tikta-Katu Rasa with Laghu, Rooksha and Tikshana Guna that aids in Sneha-Meda-Kleda Shoshana alongwith Lekhana.

6.2 REVIEW OF LITERATURE:

The Review of Literature includes screening of classical Ayurveda Literature, Modern Literature’s, scientific Journals and verified, authentic Internet sources to collect sufficient data for the study.

1. Description of Santarpana janya Vyadhi**6,7

2. Description of Bahudosha Avastha *Lakshana.*8

3. Description of Hyperlipidaemia9

4. Description of Nitya Virechana10

5. Description of Nitya Virechanain Bahudosha Avastha11

PREVIOUS WORK DONE:

1. Dr. Sreelakshmi C: Role of Ooshakadi Lekhana Basti in the management of Medopradoshajavikara w.s.r.t Hyperlipidaemia. GAMC Bangalore: RGUHS 2005.

2. Dr. Shilpa A: A comparative study on the efficacy of Virechana Karma and Badaradi Asthapana Basti inMedoroga w.s.r.t Hyperlipidaemia. GAMC Bangalore: RGUHS 2010.

3. Dr. Sumedha K A:  A comparative clinical study on Snehapana by two methods with Murchita Tila Taila followed by Virechana in Hyperlipidaemia. GAMC Bangalore : RGUHS 2013.

4. Dr. Aparna.K: A comparative clinical study to assess Virechana karma with Vidanga Tanduladi Yoga and Harithakyadi Modaka in Hyperlipidaemia. GAMC Bangalore : RGUHS 2017

5. Dr. Reeny Ravindra D: A randomized open labelled comparative clinical study to evaluate the efficacy of Virechana with and without Snehapurva Rukshana in the management of Dyslipidaemia. Sri Jagadguru Gavisiddeshwar Ayurvedic medical college, Koppal: RGUHS 2018

6. Dr. Ganesh Pai K: A comparative clinical study to evaluate the efficacy of Shodhananga Snehapana and Basti as Pravicharana with Murchita Tila taila in the management of Hyperlipidaemia. GAMC Mysore: RGUHS 2019.

7. Dr. Aishwarya Raman Gowda: A clinical study to evaluate the effect of Bahya and Abhyantara Rukshana in Shonita Abhishyanda w.s.r.t Hyperlipidaemia. Shri D G Melmalagi Ayurvedic Medical College and Hospital Gadag: RGUHS 2020.

8. Padmavati Venkatesh, Chinmayee Mohanty, & Rupendra Kumar Sahu. (2022). Role of Ubhaya Shodhana in Hyperlipidaemia- A Case Report. Journal of Ayurveda and Integrated Medical Sciences, 7(4),136 - 140. Retrieved from https://jaims.in/jaims/article/view/1814

6.3 AIM OF THE STUDY:

· To evaluate the effect of Nitya Virechana in the management of Secondary Hyperlipidaemia.

OBJECTIVES OF THE STUDY:

· To evaluate the efficacy of Ayurveda intervention (Nitya Virechana) as adjunct to standard care in the management of Secondary Hyperlipidaemia*.*

· To study Secondary Hyperlipidaemia in detail as per Contemporary science and Ayurveda

6.4 HYPOTHESIS:

· H****0 -Combined effect of Standard care and Nitya Virechana as an add-on is not effective than Control group.

· H****1 -Combined effect of Standard care and Nitya Virechana as an add-on is clinically effective than Control group.

6.5 STUDY DESIGN:

Study Type

Randomized controlled study

|Purpose

Treatment

|Masking

Open-label

|Control

Controlled

|Timing

Prospective

|End Point

Efficacy

|Number of groups

Two Groups

Group ANitya Virechana along with Standard care for Secondary Hyperlpidaemia.

Group B: Standard care for Secondary Hyperlipidaemia alone.

|Sample Size

60(30 in each arm)

7. MATERIALS AND METHODS:

The present study titled A RANDOMISED CONTROLLED TRAIL TO EVALUATE THE EFFICACY OF AYURVEDA INTERVENTION (NITYA VIRECHANA) AS AN ADD-ON TO STANDARD CARE IN SECONDARY HYPERLIPIDEMIA is a clinical trial which will be done with the following materials:

7.1 SOURCE OF DATA:

· Literary review will be done from the literature available from Central and Panchakarma Departmental library of Ayurveda Mahavidyalaya, Hubli, as well as from the modern text book, journals and Research publications. And also from internet-search engines like PubMed, Scopus, DHARA, Ayush Research Portal with keywords- Hyperlipidaemia, Santarpanajanya vyadhi, Medoroga, Nitya Virechana.

· Patient attending the Outpatient and Inpatient Department of Ayurveda Mahavidyalaya, Hubli will be identified as per inclusion-exclusion criteria and will be enrolled in the study.

· Proposed medicines to be used as Ayurveda interventions will be prepared in the Department of Rasa Shastra and Bhaishajya Kalpana, Ayurveda Mahavidyalaya, Hubli.

7.2 METHODS OF COLLECTION OF DATA:

· An informed written consent will be taken after communicating all the details of the     study in the language best understood to patient.

· The subjects will be selected randomly using simple random sampling method, irrespective of caste, religion, gender and locality.

· A designed CRF (case record form) will be prepared with all the necessary points of demography, family history, personal history, diet and lifestyle details, Nidana-Panchaka (assessment of causative factors, pathogenesis, prodromal symptoms, signs-symptoms, exacerbating/ relieving factors) as quoted in Ayurveda literature.

· The selected subjects will be subjected to detailed clinical history and complete physical examination before enrolling into the clinical study.

7.3 SOURCE OF DRUG:

Following drugs and materials will be procured from GMP certified Ayurveda drug manufacturers.

· Trikatu Churna 12 for Amapachana.

Sanskrit  name

Latin name

|Shunthi

Zingiber officinale

|Maricha

Piper  nigrum

|Pippali

Piper longum

 Â· Eranda Sneha Bharjita Triphala, Aragwadha and Katuki churna for Nitya virechana.

Quantity of Dravyas designed in the ratio 6:6:3 respectively and Erand sneha Q.S. for Nitya Virechana. The drug will beprocessed as per *Charaka Kalpastahana.*13

Sanskrit  name

Latin name

|Eranda taila

Ricinus communis

|Haritaki

Terminalia chebula

|Bibhitaka

Terminalia bellirica

|Amalaki

Emblica officinalis

|Aragwadha

Cassia fistula

|Kutki

Picrorrhiza kurrooa

 A: CRITERIA FOR DIAGNOSIS:

According to new modified NCEP (National Cholesterol Education Program) Adult          Treatment Panel III guidelines,14 following range of values will be considered for diagnosis of hyperlipidaemia.

Sr. No

Investigation

Value considered

|1

Serum .LDL  Cholesterol

130 mg/dl

|2

Serum Cholesterol

200mg/dl

|3

Serum Triglycerides

150mg/dl

|4

Serum HDL Cholesterol

<30 mg/dl

|5

S.VLDL Cholesterol

30 mg/dl

|6

Cho/HDL. Ratio

4.10

|7

LDL / HDL Cho. Ratio

3.55

B: INCLUSION CRITERIA:

1. Patients of all genders between the age group of 20-65 years who fulfil the criteria of Objective and Subjective parameters.

2. Controlled HTN - <140/90 mm of Hg.

3. Controlled NIDDM -HbA1C <7%.

4. Patients fulfilling the diagnostic criteria of Hyperlipidaemia.

5. Patients already on Antilipidemic drugs since 0-10years.

6. Patients fit forNitya Virechana.

C: EXCLUSION CRITERIA:

1. Patients newly diagnosed and not on Antilipidemic drugs.

2. Induced Hyperlipidaemia due to prolonged intake of Glucocortiosteriods.

3. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, CKD, Nephrotic Syndrome, Liver disorders etc.)

4. Patients with a past history of Atrial Fibrillation, Acute Coronary Syndrome,

5. Patient with evidence of malignancy.

6. Pregnant and lactating women.

SAMPLE SIZE â€“ 60

**GROUPING:**Sixty subjects who fulfil the inclusion criteria and are willing to participate for the study will be assigned in two groups in equal numbers i.e. 30 patients in each group randomly.

· Group -A: Nitya Virechana along with Standard care for Secondary hyperlipidaemia.

·  Group-B: Standard care for Secondary hyperlipidaemia alone.

D: INTERVENTIONS:

Group A: Nitya Virechana along with Standard care as per ACC/AHA Lipid guidelines for the management Secondary Hyperlipidaemia for period of 45 days.

Group B : Standard care as per ACC/AHA Lipid guidelines for the management Secondary Hyperlipidaemia for period of 45 days.

· Nitya Virechana Regime***:***

a. Amapachana with Trikatu churna 5gms per day before food twice a day till Nirama Lakshana appearance.

b. Nitya Virechana given with Eranda Taila Bharjita Triphala, Katuki andAragvadha based on Agni and Koshtha bala.

c. Administration Time*: Prataha kala.*

d. Anupana – Ushna Jala.

**TOTAL DURATION:**45DAYS

FOLLOW UP AFTER 15 DAYS.

WITHDRAWAL CRITERIA:

The participants will be allowed to withdraw from the trial if there is any major ailment necessitating the institution of new modalities of treatment. The decision to withdraw a participant from the trial will be taken by the principal investigator with proper justification and formal information to the ethical committee within two working days.

CRITERIA FOR ASSESSMENT OF EFFECT OF THERAPY

SUBJECTIVE PARAMETER:

Parameters and Symptoms****Score

|Shrama shwasa**(BREATHLESSNESS)**

|o Dyspnoea after heavy works (Exercise) but relieved soon and up to tolerance.

0

|o Dyspnoea after moderate works but relieved later and up to tolerance.

1

|o Dyspnoea after little works but relieved later and up to tolerance.

2

|o Dyspnoea after little work and but relieved later and beyond tolerance.

3

|ASHAKTASARVAKARMASU***(***FATIGUE)

|o No fatigue

0

|o Little fatigue on doing hard work

1

|o Moderate fatigue on doing routine work

2

|o Excessive fatigue on doing routine work

3

|MOHA**(CONFUSION)**

|o No confusion

0

|o Little confusion when mentally tired

1

|o Moderate confusion with routine mental work

2

|o Excessive confusion with routine mental work

 3

|

ALASYA***/***UTSAHAHANI (LASSITUDE)

|o No Alasyadoing work satisfactorily with proper vigor in time

0

|o Doing work satisfactorily with late initiation

1

|o Doing work unsatisfactorily under mental pressure and takes time

2

|o Not initiation of work or doing little work very slowly

3

|DAURBALYA**(PHYSICAL****INABILITY)**

|o Can do routine exercise

0

|o Can do moderate exercise without difficulty

1

|o Can do only mild exercise

2

|o Can do mild exercise with difficulty

3

|NIDRADHIKYA**(SLEEPINESS)**

|o Normal sleep 6-7 hrs. per day

0

|o Sleep up to 8 hrs. per day with Angagaurava

1

|o Sleep up to 8 hrs. per day with Angagaurava and Jrimbha

2

|o Sleep up to10 hrs. per day with Tandra

3

|SWEDADHIKYA***(***PROFUSE****SWEATING)

|o Sweating after heavy work and fast movement or in very hot season

0

|o Profuse sweating after moderate work and movement

1

|o Sweating after little work and movement

2

|o Profuse sweating after little work and movement

3

 

DAURGANDHYA**(BADODOURFROM BODY)**

|o Absence of body bad odour

0

|o Occasional bad body odour removed after bathing

1

|o Persistent bad body odour limited to closed areas difficult to suppress with deodorants

2

|o Persistent body odour limited felt from long distance not suppressed with deodorants

3

|ATIPIPASA (EXCESSIVE****THIRST)

|o Normal thirst

0

|o Up to 1 litre excess intake of water

1

|o 1 to 2 litres excess intake of water

2

|o 2 to 3 litres excess intake of water

3

|ATIKSHUDHA**(EXCESSIVE****HUNGER)**

|o As usual

0

|o Slightly increased (1 â€“2 meals)

1

|o Moderately increased (3–4 meals)

2

|o Markedly increased (5–6 meals)

3

|ANGAGAURAVA**(HEAVINESSOFBODY)**

|o No heaviness in the body

0

|o Feels heaviness in the body but it does not hamper routine work

1

|o Feels heaviness in the body which hampers daily routine work

2

|o Feels heaviness in the body which hampers movement of the body

3

OBJECTIVE PARAMETER:

1. Lipid profile

Risk levels according to the NCEP (National Cholesterol Education Program) ATP III guidelines15. For better assessment following ranges are graded as follows-

Category

Range (mg/dL)

Class

Grade

|Cholesterol LDL(C.LDL)

<130

Desirable

0

| 130-159

Border line

1

| 160-189

High

2

| 190-250

Very high

3

|Total Cholesterol(total)

<200

Desirable

0

| 200-239

Border line

1

| 240-279

High

2

| 280-350

Very high

3

|Triglycerides(TG)

<150

Desirable

0

| 150–199

Border line

1

| 200-499

High

2

| 500-550

Very high

3

|Cholesterol HDL(C.HDL)

≥60

low risk

0

| <30

High risk

1

**2.**Body Mass Index.

**3.**Waist Circumference.

**4.**Body circumference measurements:

· Chest – In normal expansion, at the level of nipple.

· Waist – At the level of the umbilicus.

· Pelvis - At the level of the highest point of distension of the buttocks

· Mid arm – Middle of the arm between the shoulder joint and elbow joint

· Mid-thigh- Mid of the thigh between the hip joint and the knee joint

· Mid-calf – Middle of the calf between the knee joint and the ankle joint.

5.  Skin fold thickness:

Skin fold thickness using vernier callipers before and after treatment in below regions

· Middle portion of the biceps muscle

· Middle portion of the triceps muscle

· Abdomen

· Thigh

 Karma Assessment:

Nitya Virechana:

· Swaroopa ofMala.(Colour and consistency)

· Vegas ofMala.

·  GI and Systemic Observations.

 Overall effect of the intervention will be estimated in the following 5 categories:

· Complete remission          100%

· Marked improvement       75 - 99%

· Moderate improvement    50 - 74%

· Mild improvement            25 - 49 %

· Un-changed                      < 25 %

STATISTICAL TESTS TO BE USED:

The statistical tests chosen in this studyconsidering Subjective and Objective parameters Paired t test will be used to find out t and p value. To compare the effect of therapy between the groups Mann Whitney Test will be used along with this appropriate test will be considered.

LABORATORY INVESTIGATIONS:

The following investigations will be done before and after treatment to rule

out any other associated pathology as well as to assess the changes after the treatment and also as safety parameters.

· Blood : Hb %

· Biochemical: HBA1C, Lipid profile.

· Urine : Routine

· USG Abdomen and pelvis

The following test will be done (If required)

· ECG

· 2D Echo

· LFT

· RFT

· Sr. Creatinine

· Thyroid profile

· Colour Doppler ( only if any coagulopathy suspected clinically or patient previous medical history relevant)

7.3 DOES THIS STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTION TO BE CONDUCTED ON PATIENTS OR ANIMALS?

YES.

This study will be conducted clinically. No animal experiments will be carried out.

  Â· HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION?

YES.

Ethical clearance has been obtained by the ethical committee constituted by Ayurveda Mahavidyalaya, Hubli and written consent will be taken from each subject or by an attendant if the subject is illiterate, on a printed consent form.

 8. REFERENCES:

1. https://en.wikipedia.org/wiki/Hyperlipidemia#cite\_note-DorlandAndAmericanHeritage-2

2.  â€œHyperlipidaemia”. The Free Dictionary. Citing: Dorland’s Medical Dictionary for Health Consumers. Saunders. 2007 and The American Heritage Medical Dictionary. Houghton Mifflin Company. 2007. ISBN 978-0618824359.

3. Lilly L (2015). Pathophysiology of heart disease : a collaborative project of medical students and faculty. Wolters Kluwer. ISBN978-1496308696.OCLC1052840871.

4. Executive summary of the Third Report of the National Cholesterol Education Program (NCEP). Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA 2001;285:2486-97.

5. https://vascular.org/patients-and-referring physicians/conditions/hyperlipidemia.

6. Agnivesha, Charaka Samhita with Ayurveda Deepika commentary of Chakrapanidatta revised by Charaka and Dridhabala, edited by Vd.Harish Chandra Singh Kushawaha, published by Chaukamba pblishers, edition 2018,  Sutra Sthana  23rd chapter page no.327-329.

7. Agnivesha, Charaka Samhita with Ayurveda Deepika commentary of Chakrapanidatta revised by Charaka and Dridhabala, edited by Vd.Harish Chandra Singh Kushawaha, published by Chaukamba publishers, edition 2018,  Nidana  Sthana  4th chapter page no..

8. Agnivesha. Charaka samhita, revised by Charaka and dridhabala, with Ayurvedadeepika Commentry of Chakrapanidatta edited by Vaidya Yadavji Trikamji Acharya Varanasi: Chowkambha Orientalia: reprint 2014. Sutra Sthana 16th chapter, Shloka 13-16, page 97.

9. Harrison’s Principles of Internal Medicine, 20edition**.**

J. Larry Jameson, Anthony S. Fauci, Dennis L. Kasper, Stephen L. Hauser, Dan L. Longo, Joseph Loscalzo

10. Dr. Kevala Krishna Thakaral. Sushruta Samhita, Chowkambha Orientalia: reprint 2017. Sushruta Samhita Chikithsa Sthana 9th chapter, shloka 68, page-309.

11. Agnivesha. Charaka Samhita, revised by Charaka and Dridhabala, with Ayurvedadeepika Commentry of Chakrapanidatta edited by Vaidya Yaadavji Trikamji Acharya Varanasi: Chowkambha Orientalia: reprint 2009. Charaka Samhita Chikithsa Sthana 13th chapter, Shloka 61, page-495.

12. Agnivesha, Charaka Samhita with Ayurveda Deepika commentary of Chakrapanidatta revised by Charaka and Dridhabala, edited by Vaidhya Yadavji Trivikramji Acharya, published by Chaukamba publishers, edition 2020, Sutrasthana 15/9-12, pg no 94.

13. Agnivesha. Charaka Samhita, revised by Charaka and Dridhabala, with Ayurvedadeepika Commentry of Chakrapanidatta edited by Vaidya Yadavji Trikamji Acharya Varanasi: Chowkambha Orientalia: reprint 2014. Kalpa Sthana 12th chapter, Shloka-48-49, page-682.

14. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001 May 16;285(19):2486-97. [PubMed]

15. National Cholesterol Education Program National Heart, Lung, and Blood Institute National Institutes of Health NIH Publication No. 01-3670 (May 2001).

               

9.

SIGNATURE OF CANDIDATE

   |10.

REMARKS OF THE GUIDE

Forwarded for the needful action

|11.

NAMES AND DESIGNATION

  |11.1.

GUIDE

DR.PADMAVATI.KULKARNI M.D. (Ayu)

PROFESSOR

DEPT. OF POSTGRADUATE PANCHAKARMA AYURVEDA MAHAVIDYALAYA, HUBLI 580024

|11.2

SIGNATURE AND SEAL

|11.3

CO-GUIDE

DR. RAMACHANDRA LATTI M.B.B.S M.D.

RTD PROFESSOR

DEPT. OF PHYSIOLOGY

PIMS RURAL MEDICAL COLLEGE

LONI, MAHARASTRA STATE

|11.4

SIGNATURE AND SEAL

   |11.5

HEAD OF THE DEPARTMENT

        DR. HARISH KULKARNI M.D (Ayu)

PROFFESOR AND I/C HOD,

DEPT. OF POSTGRADUATE PANCHAKARMA AYURVEDA MAHAVIDYALAYA, HUBLI 580024

|11.6

SIGNATURE AND SEAL

                 |12

REMARKS OF THE PRINCIPAL

Forwardedforthe needful action

|12.1

PRINCIPAL

DR. A.S. PRASHANTH M.D (Ayu) Ph.D

PRINCIPAL

AYURVEDA MAHAVIDYALAYA, HUBLI 580024

|12.2

SIGNATURE AND SEAL

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients of all genders between the age group of 20-65 years who fulfil the criteria of Objective and Subjective parameters.
  • 2.Controlled HTN -less than or equal to 140/90 mm of Hg. 3.Controlled NIDDM -HbA1C less than or equal to 7%.
  • 4.Patients fulfilling the diagnostic criteria of Hyperlipidaemia.
  • 5.Patients already on Antilipidemic drugs since 0-10years.
  • 6.Patients fit for Nitya Virechana.

排除标准

  • 1.Patients newly diagnosed and not on Antilipidemic drugs.
  • 2.Induced Hyperlipidaemia due to prolonged intake of Glucocortiosteriods.
  • 3.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, CKD, Nephrotic Syndrome, Liver disorders etc.) 4.Patients with a past history of Atrial Fibrillation, Acute Coronary Syndrome, 5.Patient with evidence of malignancy.
  • 6.Pregnant and lactating women.

结局指标

主要结局

Reduction in Cholesterol levels

时间窗: 45days

次要结局

  • Weight loss(45days)

研究者

发起方
Nandini RD
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Nandini RD

Ayurveda Mahavidhyalaya Hospital

研究点 (1)

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