| CTRI Number |
CTRI/2025/05/087285 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
14/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluate the efficacy of Yavadi Kwath in the management of Amlapitta (Hyperacidity)
|
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Yavadi Kwath in the management of Amlapitta(Hyperacidity) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shubhangi Sarangdhar Pawar |
| Designation |
Pg scholar |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya |
| Address |
Opd number 13, kayachikitsa department, C. S. M. S. S Ayurved mahavidyalaya and rugnalaya , kanchanwadi, Aurangabad, 431011
Opd number 13,kayachikitsa department, C. S. M. S. S. Ayurved mahavidyalaya and Rugnalaya, kanchanwadi, Aurangabad, 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
7028419901 |
| Fax |
|
| Email |
shubhangipawar2698@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrikant Gunwantrao Deshmukh |
| Designation |
Principal, professor, HOD |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya |
| Address |
Opd number 13 Kayachikitsa department C. S.M. S. S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad 431011
Opd number 13 kayachikitsa department, C. S. M. S. S Ayurved Mahavidyalaya and Rugnalaya kanchanwadi Aurangabad 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9921553911 |
| Fax |
|
| Email |
dr.shrikantgdeshmukh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhangi Sarangdhar Pawar |
| Designation |
Pg Scholar |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya |
| Address |
Opd no 13 kayachikitsa department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Aurangabad 431011
Opd no 13 kayachikitsa department C. S. M. S. S Ayurved Mahavidyalaya and Rugnalaya kanchanwadi Aurangabad 491011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
7028419901 |
| Fax |
|
| Email |
shubhangipawar2698@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd no 13 kayachikitsa department C.s.m.s.s Ayurved mahavidyalaya and Rugnalaya kanchanwadi aurangabad 431011 |
|
|
Primary Sponsor
|
| Name |
C.s.m.s.s Ayurved Mahavidyalaya and Rugnalaya kanchanwadi |
| Address |
kanchanwadi, Aurangabad, maharastra india 431011 |
| 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 Shubhangi Sarangdhar Pawar |
CSMSS Ayurved mahavidyalaya and Rugnalaya kanchanwadi |
Opd no 13 kayachikitsa department csmss Ayurved mahavidyalaya and Rugnalaya kanchanwadi Aurangabad
Aurangabad
MAHARASHTRA |
7028419901
shubhangipawar2698@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CSMSS Ayurved mahavidhyalaya and rugnalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K319||Disease of stomach and duodenum, unspecified. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yavadi kwath, Reference: Bharat Bhaishajya Ratnakar part- 4 shlok no.5724, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shankha vati, Reference: Bharat Bhaishajya Ratnakar part-5,shlok no 7552, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -koshnajal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1)Gender- Irrespective of gender
2)Age- 18 years to 40 years
3)Patient having clinical sign and symptoms of Amlapitta as described in Madhav nidan Ref(Madhav nidan 51/2)
Aavipak(indigestion)
utklesh
aruchi(Tastelessness)
Amla udgar(Sour belching)
Kanthadaha(Burning sensation in throat)
Klama(Fatigue)
Hruddah(Heartburn) |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Patient with any GIT,Chronic illness and Abdominal complications
Patient with diagnosed cases of Duodenal, Peptic and Gastric ulcers |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Avipak
Klama
Utklesh will be decreased |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Amla udgar (Sour belching)
Gaurav (Heaviness)
Daha (Burning sensation) will be decreased
Aruchi(Tastelessness) |
14 days |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2025 |
| 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="6"
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
|
Amlapitta has become one of the common problem in present era due to chnage in lifestyle. it is a annavaha strotas and pitta dosh dushti disease cause due to ama and mandagni.amlapitta is not mentioned in the bhrihatrayi but was first mentioned in the kashyap samhita. Tha excessive consumption of amla [sour] ,katu [spicy], ushna [hot] and viruddhashana [incompatible food combination] habits like alcohol,smoking and psycological stress can lead to an aggravation of pitta dosha. Normally ,pitta has a katu rasa [spicy taste]but when it is converted into amla rasa [sour taste], it results into amlapitta. Amlapitta caused due to mandagni, Vitiation of Agni is the main pathophysiological factor in all the disease. Amlapitta is annavaha stroto Vyadhi & amashaya being the site of disease. Hyperacidity is caused by an imbalance between the secreting mechanism of the stomach and the protective mechanism that ensure their safety. When there is an increase in the secretion of hydrochloric acid by the cell of the lining of the stomach, it is known as the hyperacidity. These increased acid levels can cause many hyperacidity symptoms. It is a condition where there is heatburn felt around the lower chest. It happen as the acid from the stomach, back up into the food pipe leading to a burning sensation. |