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CTRI Number  CTRI/2025/04/085180 [Registered on: 21/04/2025] Trial Registered Prospectively
Last Modified On: 18/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of Kiratadi Kadha (liquid) in the management of acidity. 
Scientific Title of Study   Randomized controlled clinical study of efficacy of Kiratadi Kwath and Patoladi Kwath in the management of Amlapitta. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vd Chaitali Balshiram Supe 
Designation  PG Scholar 
Affiliation  Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya  
Address  Department of Kayachikitsa, Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya, Vishwashanti Dham, Kesanand Road, Wagholi,Pune, Maharashtra, India

Pune
MAHARASHTRA
412207
India 
Phone  9653471043  
Fax    
Email  chaitalisupe2028@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vd Sushrut S Sardeshmukh 
Designation  Professor of Kayachikitsa 
Affiliation  Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya  
Address  Department of Kayachikitsa, Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya, Vishwashanti Dham, Kesanand Road, Wagholi,Pune, Maharashtra, India

Pune
MAHARASHTRA
412207
India 
Phone  9011074077  
Fax    
Email  ayuharmony@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vd Sushrut S Sardeshmukh 
Designation  Professor of Kayachikitsa 
Affiliation  Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya  
Address  Department of Kayachikitsa, Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya, Vishwashanti Dham, Kesanand Road, Wagholi,Pune, Maharashtra, India

Pune
MAHARASHTRA
412207
India 
Phone  9011074077  
Fax    
Email  ayuharmony@gmail.com  
 
Source of Monetary or Material Support  
Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya Vishwashanti Dham Kesanand Road Wagholi Pune-412207 Maharashtra India 
 
Primary Sponsor  
Name  Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya 
Address  Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya Vishwashanti Dham Kesanand Road Wagholi Pune-412207 Maharashtra India 
Type of Sponsor  Private 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 
Dr Chaitali Balshiram Supe  Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya   Department of Kayachikitsa of OPD and IPD of Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya, Vishwashanti Dham, Kesanand Road, Wagholi,Pune-412207, Maharashtra, India
Pune
MAHARASHTRA 
09653471043

chaitalisupe2028@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K318||Other specified diseases of stomach and duodenum. Ayurveda Condition: AMLAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Kiratadi Kwath, Reference: "Ras Ratnakara" : Anuvadak-Lalashalgraamji published by Shri Venkateshwar Press Mumbai, Khemraj Shrikrushnadas Prakashan 2018 ,Mumbai Amlapittachikitsa adhikara, Shlok number 8,page no-676 , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Patoladi Kwath, Reference: Ayurvedacharya Shrilaxmipathu Shastri: Yogaratnakar: Vidyotini tindi Tikasahit: Revised edition 2012: published by Chaukamba Prakashan, Varanasi: Uttarardh Amlapitachikitsa Shlok no 4, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients having symptoms of Amlapitta.
2. Patients having duration of symptoms more than 1 month and less than 2 years.
3. Patients having at least the presence of 4-5 symptoms will be selected.
4. Patients between age group 18 to 60 years of either gender. 
 
ExclusionCriteria 
Details  1. Patient with known case of gastric ulcer, duodenal ulcer, stomach cancer.
2. Patient suffering from Diabetes mellitus, Hypertension ,Thyroid disorders and
any other co morbidity.
3. Long-term addictions like alcoholism, smoking, tobacco chewing, drugs etc.
4. Pregnancy and lactating women. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To observe and document the efficacy of Kiratadi Kwath in the management of Amlapitta.   Assessment of 0th 7th 14th Day 
 
Secondary Outcome  
Outcome  TimePoints 
To find out adverse effect of Kiratadi Kwath if any  Assessment of 0th 7th 14th Day 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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 
Date of First Enrollment (India)   01/05/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
The current study is randomized controlled clinical study of efficacy of Kiratadi Kwath and Patoladi Kwath in the management of Amlapitta. Total 68 diagnosed patients will be divided into two equal groups - Experimental group and Control group. The treatment for experimental group is Kiratadi Kwath 40 ml with honey twice a day for 14 days and control group is Patoladi Kwath 40 ml with honey twice a day for 14 days and assessment will be done on 0th, 7th, 14th day. 
In 21st century, lifestyle is completely changed by all the means, our diet pattern, stress, behavioral patterns , etc. Nowadays younger generation are mostly attracted towards spicy, junk, processed food causing digestive problems which leads to Non ulcer Dyspepsia rather than consuming healthy, nutritious, nourishing food. The prevalence rate of Non-ulcer Dyspepsia in India is 30.4%. Modern Science recommends the treatment of proton pump inhibitors, H2blockers, antacids which have symptomatic relief, but is not reliable for long term and are liable to have many side effects like osteoporosis, bone fractures, Kidney disease, etc.
Non ulcer Dyspepsia describes symptoms such as discomfort, bloating and nausea, pain in the upper abdomen, vomiting which are thought to originate from upper gastrointestinal tract The symptoms of Amlapitta are similar to signs and symptoms of Non-ulcer Dyspepsia.
Ayurveda recommends Shaman Chikitsa (Internal treatment) as well as Shodhan Chikitsa (detoxification treatment) for the treatment of Amlapitta. Kiratadi Kwath mentioned in Ras Ratnakar (ayurvedic text) of Amlapitta Chikitsa Adhyay is Kaphagna, Pittashamaka, Deepan, Amapachan which breaks the Samprapti of Amlapitta and helps to relieve the symptoms. These contents are herbal, economical and easily available.
 
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