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CTRI Number  CTRI/2023/03/050890 [Registered on: 20/03/2023] Trial Registered Prospectively
Last Modified On: 15/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   An open label clinical trial to evaluate the efficacy of Vamana Karma ( Emesis) in the management of Urdhwaga Amalpitta (Hyperacidity and Gastritis ).”  
Scientific Title of Study   An open label clinical trial to evaluate the efficacy of Vamana Karma in the management of Urdhwaga Amalpitta.”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neetu chauhan 
Designation  M D Panchkarma Scholar 
Affiliation  Shri krishna gov. ayurvedic college and hospital kurukshetra haryana 
Address  Room no 29 Shri Krishna govt. Ayurvedic college and hospital Kurukshetra Haryana
Shri Krishna govt. Ayurvedic college and hospital Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India 
Phone  09927044063  
Fax    
Email  neetuharidwar1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Ashish Mehta 
Designation  Head, P.G Department of Panchkarma 
Affiliation  Shri krishna gov. ayurvedic college and hospital kurukshetra haryana 
Address  Room No 67 1st Floor Shri Krishna gov. ayurvedic college and hospital Kurukshetra Haryana
Shri Krishna gov. Ayurvedic college and hospital Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India 
Phone  9468319930  
Fax    
Email  drashishhmehta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Neetu chauhan 
Designation  M D Panchkarma scholar  
Affiliation  Shri krishna gov. ayurvedic college and hospital kurukshetra haryana 
Address  room no 29 Shri Krishna gov. Ayurvedic college and Hospital Kurukshetra Haryana
Shri Krishna gov. Ayurvedic college and hospital Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India 
Phone  09927044063  
Fax    
Email  neetuharidwar1@gmail.com  
 
Source of Monetary or Material Support  
Shri Krishna Government Ayurvedic College and Hospital kurukshetra 
 
Primary Sponsor  
Name  Shri Krishna Government Ayurvedic College and Hospital kurukshetra 
Address  Shri Krishna Government Ayurvedic College and Hospital Sec 8 Umri Road Kurukshetra HARYANA 136118 India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Neetu chauhan   shri krishna gov. ayurvedic college and hospital  Department of Panchkarma, 1st Floor, Room No 29,
Kurukshetra
HARYANA 		 09927044063

neetuharidwar1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee of University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K290||Acute gastritis. Ayurveda Condition: URDHVAGATA-AMLAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् Pradhan Karma(Procedure Reference: Bhaishajya Ratnavali, Procedure details: First 7 days - Sneha Pana 8th-9th day - Abhyanga & Swedana 9th day - Vamana Karma 9th-15th day - Samsarjana Krama)
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patients having classical sign and symptoms of Urdhwaga Amlapitta as per Ayurvedic
classics.
2. Patient having cardinal symptoms of gastritis and hyperacidity with the duration not more
than one year.
3. Male or female between the age group 25- 50 year.
4. Patients who are fit for Vaman Karma as per ayurvedic classics. 
 
ExclusionCriteria 
Details  1. Patients below 25 years and above 50 years.
2. Patients of Amlapitta with any chronic system disease which interferes with the present
study.
3. Patients suffering from any current acute illness.
4. Patients having associated complicated systemic disorders like cardiac diseases, diabetes,
tuberculosis, bronchial asthma, autoimmune diseases etc.
5. Known case of gastric and duodenal ulcer.
6. Known case of gastric carcinoma.
7. Chronic gastritis (more than one year)
8. Hiatus hernia, Barrett’s esophagus.
9. Patients with the previous history of hematemesis, hemoptysis or melena.
10. Patients having congenital physiological anomalies, surgical interventions, and any trauma.
11. Patients who are contraindicated for Vaman Karma. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
primary outcome Relieve in the sign and symptoms of Urdhwaga Amlapitta as per subjective criteria
 		 at the baseline of 20th 40th & 60th day
 
 
Secondary Outcome  
Outcome  TimePoints 
➢ The lifestyle of patient improved after the treatment. Patient can perform daily routine
activity without any trouble.
➢ He/she can enjoy the food and lifestyle of his/her choice.  		 at the baseline of within or after the 60th day.  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 3/ Phase 4 
Date of First Enrollment (India)   01/04/2023 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Nowadays Pitta Vardhaka Ahar Vihar is becoming major part of present life style excessive intake of junk food, salty, spicy & fried food, frequent use of NSAIDs, antibiotics, steroids and aspirin like medicines and vihar like fasting, eating between the meals( adhyashan), having food in hurry & worry, suppression of urges, derange the pachak pitta thus developing a condition called amlapitta. Prakrita rasa of pitta is bitter ( katu). Amlapitta is a condItion where prakrita rasa of pitta changes from bitter to sourer. 
Amlapitta is characterized by aruchi (anorexia), gurukosthatva ( heaviness in abdomen), klama ( lethargy), vibandh ( constipation), shiroruja ( headache ), hrutakanthadaha ( burning sensation in chest ), tiktoamlaudgara ( bitter and sour belching ) as general symptoms ).
Acharya Charak in Charak Samhita has not described amlapitta as a disease. He has mentioned that when annavisha combines with pitta & amlapitta occurs. Acharya Madhava & Acharya Kashyap described the disease in detail and classified it on the basis of gati i.e., ( urdhwaga amlapitta & adhoga amlapitta) and sansarga of dosha ( sanila amlapitta & sanila kaphaja amlapitta).
Sign and symptoms of amlapitta is very similar to gastritis and hyperacidity. 
Vaman karma is a treatment of choice for the urdhwaga amlapitta as mentioned in the Bhaishjyaratnavali.
In urdhwagaamlapitta vititated pitta and kapha are the key factors responsible for whole Pathological process. Vaman karma is indicated as shodhana karma for urdhawaga amlapitta. The symptoms of urdhwaga amlapitta are due to the disturbance in dravata and ushnata of pachak pitta and snigdhata of kledak kapha. Vaman is found to be effective in urdhawga amlapitta which is amashaya janya vyadhi and in vaman amashaystha doshas are expelled out. 
 
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