| CTRI Number |
CTRI/2022/05/042777 [Registered on: 24/05/2022] Trial Registered Prospectively |
| Last Modified On: |
23/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A medicine in form of churana for hyperacidity |
|
Scientific Title of Study
|
A Randomized clinical study of Pathyadi churna along with kunjal kriya in amlapitta roga(Hyperacidity) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pramod Kumar MIshra |
| Designation |
Head of Department and Professor |
| Affiliation |
Rajasthan Ayurved University |
| Address |
Dept. of Swasthavritta room no 1,Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur
Room no 18 Dept. of swasthavritta, hospital OPD block, hospital of ayurved university, jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9001068900 |
| Fax |
|
| Email |
drpramodmishra4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Mishra |
| Designation |
Head of department, PG Department of Swasthavritta |
| Affiliation |
Rajasthan Ayurved University |
| Address |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur
Room no 18 Dept. of swasthavritta, hospital OPD block, hospital of ayurved university, jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9001009793 |
| Fax |
|
| Email |
Drpramodmishra4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj Meena |
| Designation |
MD Scholar |
| Affiliation |
Rajasthan Ayurved University |
| Address |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur
quarter no 4, type 1, Rajasthan Ayurved University, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9001068900 |
| Fax |
|
| Email |
Mkmeena3@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University karwar Jodhpur |
| Address |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University karwar Jodhpur |
| Type of Sponsor |
Government 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 Manoj Meena |
University Hospital of Ayurveda |
P.G. Department of Swasthavritta and yoga, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University karwar Jodhpur
Jodhpur
RAJASTHAN |
9001068900
Mkmeena3@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The institutional ethical Committee DSRRAU Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K290||Acute gastritis. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kunjal kriya | (Procedure Reference: Gherand samita 1/39, Procedure details: In the morning, take 3-5 liter of lukewarm water and drink until vomit spell out)
| | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: PATHYADI CHURANA, Reference: CHAKARDUTT SAMUTA 52/13, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -MANDOUSHANA), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 16 to 50 years.
2. Clinically and pathologically diagnosed patients, who are suffering from amlapitta (Hyperacidity) for the last 3 months.
3. Subject not taking any other medication |
|
| ExclusionCriteria |
| Details |
1. subject should not be suffering from amlapitta for more than 3 months.
2. age below 16 years and above 50 years.
3. subject reporting complications like cardiac problems, emphysema, carcinoma, etc.
4. pregnant women and lactating mothers will be excluded.
5. subjects with severe vomiting and dehydration.
6. subject with gastric malignancy.
7. subject who recently undergo gastrointestinal surgery. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
subjective parameters will be:
1. avipak (indigestion)
2. klama (tiredness)
4. utklesh (nausea)
5. tiktamlaudgara (sour and bitter belching)
6. guruta (heaviness)
7. hritkanthdaha (heart and throat burn)
8. aruchi (anorexia) |
1. total assessment will be for 1 month.
2. follow up period for assessment will be of 7 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement will be assessed on the basis of relief found in signs and symptoms of amlapitta. The subjective parameters will be:
1.indigestion
2.tiredness
4.nausea
5.sour and bitter belching
6.heaviness
7.heart and throat burn
8.anorexia |
the assessment period will be of 30 days. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/05/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/05/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is randomized, with two groups one is who use Pathyadi Churna and another is who use Kunjal Kriya for 1 month in 40 patients, conducted at the hospital of university college of Ayurveda jodhpur. 1. To evaluate the effect of Pathyadi Churana as mentioned in Ayurvedic texts in the management of Amlapitta. 2. To evaluate the effect of Kunjal Kriya as mentioned in ayurvedic texts. |