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Clinical Trials/CTRI/2024/11/077122
CTRI/2024/11/077122
Recruiting
Phase 3

A COMPARATIVE PHARMACOLOGICAL AND CLINICAL STUDY TO EVALUATE THE EFFICACY OF TEJAS YOGA AND MEDOHAR GUGGULU IN THE MANAGEMENT OF MEDODUSHTI W.S.R. TO DYSLIPIDEMIA

Department of Kayachikitsa1 site in 1 country40 target enrollmentStarted: December 31, 2024Last updated:

Overview

Phase
Phase 3
Status
Recruiting
Sponsor
Department of Kayachikitsa
Enrollment
40
Locations
1
Primary Endpoint
Tejas yoga will be efficacious in the management of dyslipidemia

Overview

Brief Summary

The growing challenges of modernization have resulted in human beings readjusting their

customary behaviour by modifying their dietary and lifestyle preferences. Fast foods, lack of

exercise, stress, and various addictions are some of the factors that are adversely impacting the

lifestyle of man in the 21st century.

In ayurveda Medodushti can be corelated with Dyslipidemia. A person having Avyayama,

Achinta, Diwaswapna, Atisnigdha, Madhura, Adhyashan, Atimatra Ahara and Beejaswabhava

leads to medovaha srotodushti.

In due course of time Srotorodha (Blockage) of medovaha srotas effect tissue metabolism

which leads to Medoroga and its associated disorders like Sthaulya, Prameha, Kushtha,

disorders of Ama, Napunsakata, Dysuria.

Aetiological factor like: high fatty diet (Snighdha, Guru, Pichhila) and Sedentary Lifestyles

(Cheshtadvesha, Asana sukha) may contribute to Medovruddhi, a Santarpanjanya vyadhi in

Ayurveda which finally leads to morbidity of Kapha Dosha and Medo Dhatu. Due to

Medodhatvagni Dushti excessive accumulation of abnormal Kapha and Meda occurs in various

Srotas in body.

Sama Kapha - Sama Meda present in Rasa-Raktavaha Srotasa results in obstruction to the

movement of Vata & Rakta through affected srotas, which finally ends up in disease

manifestation according to the site of affliction. The state of Sama Kapha and Sama Medodhatu

and its excessive presence, margavarana in Rasa-Raktavaha Srotasa is often compared with the

state of dyslipidemia.

The term ‘Dyslipidemia’ denotes disordered lipid metabolism. It is defined as the presence of

raised or abnormal levels of lipids and/or lipoproteins in the blood. Dyslipidemia may result

from inborn defects of lipoprotein production or metabolism; but in most cases, it is secondary

to an unhealthy lifestyle (e.g. excessive cigarette smoking or alcohol consumption), other

health disorders (e.g. obesity, diabetes, infection, and obstructive liver disease), or medication

(e.g. β blockers, steroids).

Dyslipidemia is the disorder which has been identified as a potential risk factor for many

diseases, including cardiovascular diseases, metabolic syndrome, and hypertension.

Dyslipidemia has drawn worldwide interest for its ability to participate in the pathology of

atherosclerotic diseases by its deposition in the walls of arteries. It is responsible for many

life threatening condition like coronary artery disease (CAD), Ischemic heart disease,

hypertension and stroke, which is an important cause of morbidity and mortality the world

over.

Worldwide, cardiovascular disease is now one of the most common cause of death. The large

number of cases get diagnosed of Dyslipidemia while evaluating the Lipid profile of the patient.

Epidemiological study predict that for each 1% reduction in lipid level, the risk of heart diseases

reduces by 2.5%.

In modern system of medicine, we have wide range of drugs like statins, resins, fibric acid

derivatives, nicotinic acid, etc. which are quite effective in normalising the lipid levels. But

they may cause some side effects like headache, nausea, bowel upset, rashes, sleep

disturbances, myalgia, liver damage etc.

Keeping in mind above facts, it can be said that the final purpose of management of

dyslipidemia is to stop the formation of Sama Kapha and Sama Meda and to clear the

Srotorodha and then re-establishing the normal movement of Vata. Hence, Tejas yoga having

Ushna, Tikshna, Katu, Kaphavata shamak and Srotoshodhaka properties was selected for

management of Medodushti (dyslipidemia), which can help to break the Samprapti or clear the

Ama, Kapha, and Meda and to clear the Avarana and then re-establishing the normal movement

of Vata can help to manage the symptoms of dyslipidemia.

In the present study two drugs were selected for comparison ,first one is Medohar guggulu the

standard drug which is already given on our text and 2nd formulation is Tejas yoga whose drugs

are selected on the basis of their effect on medodhatu and having hypolipidemic activity.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Age above 20 years and below 60 years.
  • Patient with abnormal value of Total cholesterol, Serum triglyceride, LDL, VLDL, HDL A following range value was taken for diagnosis of Dyslipidemia.
  • Cholesterol 200-239 mg/dl or/and S.
  • Triglyceride 200-399 mg/dl or/and S.L.D.L 130-159 mg/dl or/and S.H.D.L more than 40 mg/dl.

Exclusion Criteria

  • Age below 20 year and above 60 years.
  • Liver cirrhosis
  • Liver failure
  • Nephrotic syndrome
  • Chronic renal failure
  • Tuberculosis
  • Patients having H/o – Serious cardiac disorder like MI or cardiac failure.
  • Pregnant female and lactating mothers.
  • Patients suffering from D.M. that were poorly controlled and uncontrolled hypertension.
  • Patients taking allopathic medication for dyslipidemia like statins, fibrates derivatives along with ayurvedic medication or does not agree for only ayurvedic medication.

Outcomes

Primary Outcomes

Tejas yoga will be efficacious in the management of dyslipidemia

Time Frame: 12 weeks

Secondary Outcomes

  • Tejas yoga will be more efficacious than medohara guggulu in the management of dyslipidemia(1 year)

Investigators

Sponsor
Department of Kayachikitsa
Sponsor Class
Other [Government Ayurved College ]
Responsible Party
Principal Investigator
Principal Investigator

Masum Sharma

Shri NPA Government Ayurveda College Raipur Chhattisgarh

Study Sites (1)

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