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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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: - | 2 | Comparator Arm | Drug | Classical | | (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. |