| CTRI Number |
CTRI/2020/09/027968 [Registered on: 22/09/2020] Trial Registered Prospectively |
| Last Modified On: |
21/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of effect of Guduchyadi decoction in acidity. |
|
Scientific Title of Study
|
Comparative Prospective Phase II Clinical Study to Evaluate the Efficacy of Guduchyadi Kwatha in Urdhvaga 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 |
Nitin Motiram Karhale |
| Designation |
P G Scholar |
| Affiliation |
Ayurved sevha sangh Ayurved mahavidyalaya Nashik |
| Address |
OPD no 13 Kayachikitsa opd
Nashik
MAHARASHTRA
422003
India |
| Phone |
7038345758 |
| Fax |
|
| Email |
drkarhalenitin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajan Balwant Kulkarni |
| Designation |
Professor and Guide |
| Affiliation |
Ayurved sevha sangha Ayurved mahavidyalaya nashik |
| Address |
OPD no 13 Kayachikitsa opd
Nashik
MAHARASHTRA
422003
India |
| Phone |
9823350440 |
| Fax |
|
| Email |
vaidyarajankulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajan Balwant Kulkarni |
| Designation |
Professor and Guide |
| Affiliation |
Ayurved sevha sangha Ayurved mahavidyalaya nashik |
| Address |
OPD no 13 Kayachikitsa opd
Nashik
MAHARASHTRA
422003
India |
| Phone |
9823350440 |
| Fax |
|
| Email |
vaidyarajankulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ayurved Mahavidya Nashik |
| Address |
OPD no 13 Kayachikitsa opd Ayurved sevha sangh ayurved mahavidyalaya panachvati nashik |
| Type of Sponsor |
Other [Govt Aided Institute] |
|
|
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 Nitin Motiram Karhale |
Arogyashala Rugnalaya |
OPD no 13 Kayachikitsa OPD Ayurved Mahavidyalaya Nashik
Nashik
MAHARASHTRA |
7038345758
drkarhalenitin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ayurved Seva Sangh Ayurved Mahavidyala Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hyperacidity |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bhunimbadi Kwatha |
40 ml two times a day before meal with honey for 21 days |
| Intervention |
Guduchyadi Kwatha |
Orally 40 ml two times a day before meal with honey for 21 days |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients having symptoms of urdhvag amlapitta
patients willing for trial and giving consent
patient from all socio economic status |
|
| ExclusionCriteria |
| Details |
pregnent and lactating women
patients having hepatic disorders and other complications
patient suffering from any infectious diseases
patient suffering from major illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
chest burning reduced
vomiting reduced
abdominal pain reduced |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hyperacidity Reduced |
21 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
25/09/2020 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
According to Ayurveda any disease can be caused when there is vitiation of Agni, dosha, mala,dhatu, and manasbhava.if any factor among this is disturbed it is called as vikara .according to ayurved agni plays main role in the physiological functioning of the body. the main root cause of all disease in mandagni. ’viruddhaashana’ for example fish with milk , etc pittaprakopak Aahara like spicy Food ,tea and alcohol causes pitta dosha in our body gets exaggerate which lead to symptoms of urdhvag amlapitta.Guduchyadi kwatha is a combination of Guduchi, patola,Chitrak, and Nimba as given in yogratnakara. they have properties of deepana ,pachana, and pittashamana so we used this combination in urdhvag amlapitta. |