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Clinical Trials/CTRI/2024/07/071038
CTRI/2024/07/071038Not yet recruitingPhase 2/3

Randomized Clinical Study Of Virechan Karma And Narikel Khand Pak In Amlapitta With Special Reference To Hyperacidity

LRP Ayurvedic Hospital And Research Centre1 site in 1 country80 target enrollmentStarted: August 2, 2024Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
To Study The Effect Of Virechan Karma And Narikel Khand Pak In Amlapitta

Study Overview

Brief Summary

Amlapitta can be included under the broad heading of Gastro Esophageal Reflux Disease. Now in present era, due to bad food habits & faulty lifestyle.It becomes a burning problem in India and also all over the world.It is characterized by Amloudgara (sour, bitter rush) Hritkanthadaha (burning sensation in chest), Utklesh (vomiting), Avipak (indigestion), Aruchi (anorexia), klama (fatigue) ,Nil pitta Varna and Gandha yuktta Malapravrutti, Mandagni indicating the vikriti of pachak pitta along with kledak kapha and saman vayu. Amlapitta was first describe by Acharya Kashyapa in detail with separate chapter . In ancient classical textbook Charak Samhita Amlapitta was describe with its causes and pathogenesis. According to Ayurveda Amlapitta is divided in two types Urdhavaga Amlapitta and Adhoga Amlapitta.This disease can be corelated with Hyperacidity base on the clinical features. Hyperacidity is a disease occuring due to improper diet,lifestyle and improper digestion. Patient with Hyperacidity have signs & symptoms such as heart burn, chest pain, gastric discomfort, abdominal distention, sour blenching, food regurgition, nausea & reduced appetite. The annual death rate was 0.20/100,000. The causes were hemorrhagic reflux esophagitis in 51.9%,Aspiration pneumonia in 34.6%, perforation of esophageal ulcer in 9.6%, and spontaneous esophageal rupture with reflux esophagitis in 3.9%. Shodhan and shaman both treatments are mentioned for Amlapitta. Shodhan can rule out excessive vikrit doshas.In Shaman chikitsa mainly tikta rasa Pradhan pachak aushadhis and Kapha-pittaghna chikitsa should be given. Recurrence of Vikrit doshas is not possible with shodhan purvak shaman chikitsa. It may reoccur if only shaman chikitsa have operated. So, shaman treatment after the shodhan procedure is more reliable than either shaman or shodhan treatment.  Though Amlapitta is mainly associated with pitta doshas and the excellent treatment for pitta dosha is virechan. Associated in this disease, therefore for complete irradiation from this disease. Acharya Chakradatta narrated to give virechan karma according to patients bala (strength)4 . The drug Narikel Khand Pak is selected for the shaman chikitsa which has Tikta Katu and madhur ras pradhan dravyas and have Agnidipan, Pachan and Pitta doshahara Vatakaphahar properties.Though to study efficacy of this drug in Amlapitta Narikel Khand Pak is selected.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

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

Inclusion Criteria

  • 1.Patient will be selected irrespective of gender occupation and habitat.
  • 2.Those who are fit for virechan procedure.
  • 3.Patients presenting with classic sign and symptoms of Amlapitta.

Exclusion Criteria

  • 1.Age below 20 years and above 60 years.
  • 2.Those who are not fit for Virechan procedure.
  • 3.Patient having history of hyper acidity due to secondary underling cause like oesophageal carcinoma.
  • 4.Patients diagnosed with gastric and duodenal ulcer.

Outcomes

Primary Outcomes

To Study The Effect Of Virechan Karma And Narikel Khand Pak In Amlapitta

Time Frame: 48 days

Secondary Outcomes

  • To Reduce the Almapitta in 48 days(To study the literature related to concept of Amlapitta)

Investigators

Sponsor
LRP Ayurvedic Hospital And Research Centre
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Akshaykumar Mote

LRP Ayurvedic medical college and hospital

Study Sites (1)

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