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