| CTRI Number |
CTRI/2024/07/071038 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Study The Effect Of Virechan Karma And Narikel Khand
Pak In Amlapitta With Special Reference To Hyperacidity |
|
Scientific Title of Study
|
Randomized Clinical Study Of Virechan Karma And Narikel Khand
Pak In Amlapitta With Special Reference To Hyperacidity |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akshaykumar Mote |
| Designation |
MD scholar Panchakarma (Ayurveda) |
| Affiliation |
LRP Ayurvedic medical college and hospital |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur sangli, Department Of Panchakarma,Unit 2,Room no.1
Sangli
MAHARASHTRA
415409
India |
| Phone |
8600949488 |
| Fax |
|
| Email |
akshaymote2012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay chavan |
| Designation |
Professor |
| Affiliation |
LRP Ayurvedic medical college and hospital |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur sangli, Department Of Panchakarma,Unit 2,room no. 1.
Sangli
MAHARASHTRA
415409
India |
| Phone |
9511845191 |
| Fax |
|
| Email |
purvachavan007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinay chavan |
| Designation |
Professor |
| Affiliation |
LRP Ayurvedic medical college and hospital |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur sangli, Department Of Panchakarma,Unit 2,room no. 1.
Sangli
MAHARASHTRA
415409
India |
| Phone |
9511845191 |
| Fax |
|
| Email |
purvachavan007@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College and Hospital Urun Islampur Sangli Maharashtra India PIN code-415409 |
|
|
Primary Sponsor
|
| Name |
LRP Ayurvedic Hospital And Research Centre |
| Address |
LRP Ayurvedic Medical College Hospital Post Graduate Institute and Research Centre Islampur sangli Maharashtra India PIN code-415409 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akshaykumar Nana Mote |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre |
Department of Panchakarma,Unit no.2,Room no.1 LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur sangli 415409
Sangli
MAHARASHTRA |
8600949488
akshaymote2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K219||Gastro-esophageal reflux disease without esophagitis. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: sharangdhar samhita, Procedure details: Virechan yog (triphala,Nishottar,madhu) will be prepared in Department of Panchakarma in our
institute with the reference of sharangdhar samhita madhyam khand
2/1-2, Virechan yog will be given according to koshta)
(1) Medicine Name: Narikel Khand Pak, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Khanda/Granules, Dose: 5(g), Frequency: bd, Duration: 1 Months | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Narikel Khand Pak, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Khanda /Granules, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: koshna Jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study The Effect Of Virechan Karma And Narikel Khand Pak In Amlapitta |
48 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Reduce the Almapitta in 48 days
To study the literature related to concept of Amlapitta
To study the concept of virechan karma
To study the concept of Narikel khand Pak
|
12 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |