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CTRI Number  CTRI/2025/01/078850 [Registered on: 16/01/2025] Trial Registered Prospectively
Last Modified On: 31/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Patoladi Kwath and Patoladi Kwath Ghan Vati in Amlapitta (Acid Peptic Disorder) 
Scientific Title of Study   To Compare the Efficacy of Patoladi Kwath with Patoladi Kwath Ghan Vati in Amlapitta wsr Acid Peptic Disorder - A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kanika Aggarwal 
Designation  MD Scholar (Department of Kayachikitsa) 
Affiliation  Ch Brahm Prakash Ayurved Charak Sansthan 
Address  Department of Kayachikitsa Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh

South West
DELHI
110073
India 
Phone  9999670338  
Fax    
Email  kanikag96@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr N R Singh 
Designation  Head of Department 
Affiliation  Ch Brahm Prakash Ayurved Charak Sansthan 
Address  Department of Kayachikitsa Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh

South West
DELHI
110073
India 
Phone  9560659728  
Fax    
Email  naimishraj@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Prof Dr N R Singh  
Designation  Head of Department  
Affiliation  Ch Brahm Prakash Ayured Charak Sansthan 
Address  Department of Kayachikitsa Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh

South West
DELHI
110073
India 
Phone  9560659728  
Fax    
Email  naimishraj@yahoo.com  
 
Source of Monetary or Material Support  
Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar , Najafgarh, South west delhi 110073, India 
 
Primary Sponsor  
Name  Ch Brahm Prakash Ayurved Charak Sansthan 
Address  Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh, New Delhi 110073 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Kanika Aggarwal  Chaudhary Brahm Prakash Ayurved Charak Sansthan  Room number 108, PG Department of Kayachikitsa Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh
South West
DELHI 
9999670338

kanikag96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of CBPACS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K279||Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation. Ayurveda Condition: AMLAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Patoladi Kwath, Reference: Yogratnakara Uttaratantra Chapter number 57 shloka number 26 , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Patoladi Kwatha Ghana Vati , Reference: Yogratnakara Uttaratantra Chapter number 57 shloka number 26 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: -
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Any one or more clinical features of Amlapitta as described in Ayurvedic texts viz Amlodgaar Tiktodgaar Kantha daah Urah daah Aruchi Utklesha Avipaka Gaurav Klama and Shiroruk for more than one month and up to 2 years 2. Subjects of Age group between 21 to 60 years 3. Subjects not having any other serious illness 4. Subject willing to participate in the study and ready to give informed consent 5. Subjects not registered in any other research projects 
 
ExclusionCriteria 
Details  1. Age group less than 21 years and more than 60 years 2. Known cases of Gastric and Duodenal ulcers and gastric carcinoma 3. Pregnant or lactating women 4. Subjects taking NSAID & whom the investigators judge to be unsuitable to participate in the clinical trial (diagnosed psychotic illnesses, substance dependence, or alcoholism). 5. Subjects with major systemic illnesses, including cardiac disease, liver disease, kidney disease, uncontrolled diabetes, uncontrolled hypertension, inflammatory bowel disease, psychoneuroendocrinal disorders, etc. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in symptom severity of Amlapitta (Acid peptic disorder)
Avipaka (Indigestion)
Tiktaudgara (Bitter eructation)
Kantha daha (Burning in throat)
Gaurav (Heaviness in body)
Utklesa (Nausea)
Klama (Lassiitude)
Aruchi (Loss of appetite)
Hritdaha (Heart Burn)
Amlaudgara (Sour eructation)
Shiroruk (Headache)
 
30 days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   23/01/2025 
Date of Study Completion (India) 16/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 correlated with acid peptic disorder. Amlapitta is a condition in the upper gastrointestinal tract caused by abnormal Pitta pathological conditions. It involves an increase in Pachak pitta and a change in Pitta’s bitter taste to a sour taste. According to Acharya Kashyapa, Nidana sevana causes Doshaprakopa, particularly of Pitta Dosh, which creates Mandagni, which in turn creates Vidagdha and Shuktibhava in food, leading to Amlata in Amashaya. The first and foremost group of etiological factors of Amlapitta may be considered a dietary factor. Acharya Sushruta has mentioned a symptom known as Amlika, which results from excessive use of Lavana rasa and is similar to Amlapitta (acid peptic disorder). Common symptoms include heartburn, regurgitation, dysphagia, altered appetite, satiety, vomiting, nausea, and epigastric pain. Gastric juices contain pepsin and hydrochloric acid, breaking down proteins into peptides and peptones. The stomach’s filling and emptying activities are regulated by signals from the stomach and duodenum, with factors like enterogastrin inhibiting emptying. The stomach wall is impermeable to most substances, preventing absorption until the small intestine. However, some substances, like water, ions, drugs, and alcohol, are absorbed. Antacids, proton pump inhibitors (PPI), and H2 inhibitors are commonly used medicines to neutralize stomach acid and relieve symptoms. However, their widespread use has led to long-term adverse effects, including increased risk of kidney, liver, and cardiovascular disease, dementia, gastrointestinal tract tumours, susceptibility to infections, and impaired nutrient absorption. Long-term use also causes rebound acid production, abdominal pain, nausea, osteopenia, and constipation. The present study aims to evaluate the role of Patoladi Kwath and Patoladi Kwath Ghan Vati in improving symptoms of Amlapitta. The total number of patients is 80, 40 in each group. In group A, Patoladi Kwath will be administered a dose of 40 mL twice a day with lukewarm water on an empty stomach. In group B, Patoladi Kwath Ghan Vati is administered in a dose of 2 tablets, 500 mg each, twice a day with lukewarm water after food. The study design is a single-centred, open-labelled, randomized, comparative, interventional study.


 
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