| CTRI Number |
CTRI/2021/03/031950 [Registered on: 12/03/2021] Trial Registered Prospectively |
| Last Modified On: |
11/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Vamandhauti procedure and Shivapalapindi Choorna administration in Gastric disease |
|
Scientific Title of Study
|
To Evaluate the efficacy of Vamana dhauti with and without Shivapalapindi in Amlapitta |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chaudhari Krishnakumari B |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College Mysuru |
| Address |
Room number 12, Department of Swasthavritta, Govt. Ayurveda Medical College and Hospital
New Sayyaji Rao Road
Mysore - Karnataka
Mysore
KARNATAKA
570001
India |
| Phone |
9664931100 |
| Fax |
|
| Email |
krishnachaudhari2680@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rekha BV |
| Designation |
Professor |
| Affiliation |
Government Ayurveda Medical College Mysuru |
| Address |
Room Number - 12, Department of Swasthavritta, Govt. Ayurveda Medical College
New Sayyaji Rao Road
Mysore
Mysore
KARNATAKA
570001
India |
| Phone |
8073046886 |
| Fax |
|
| Email |
nisargarekha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr CHAUDHARI KRISHNAKUMARI B |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College Mysuru |
| Address |
Room number - 12, Department of Swasthavritta, Govt. Ayurveda Medical College
New Sayyaji Rao Road
Mysore
Mysore
KARNATAKA
570001
India |
| Phone |
9664931100 |
| Fax |
|
| Email |
krishnachaudhari2680@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical Collage & Hospital, New sayaji rao road, mysuru |
|
|
Primary Sponsor
|
| Name |
Dr Chaudhari Krishnakumari B |
| Address |
GOVERNMENT AYURVEDA MEDICAL COLLEGE, MYSURU
|
| Type of Sponsor |
Other [PG Scholar] |
|
|
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 Chaudhari Krishnakumari B |
Government Ayurveda Medical Collage and Hospital, Mysuru |
Room number - 12, Departmnet of Swasthvritta, new sayaji rao road, Mysuru
KARNATAKA
Mysore
KARNATAKA |
9664931100
krishnachaudhari2680@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr CHAUDHARI KRISHNAKUMARI B |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1- Vaman dhauti
2- SHIVAPALA PINDI |
1-giving lukewarm saline water in empty stomach and making the patients vomit.
Duration - once only at the beginning of trail
Route of administration- Oral
2- Patha, Patola, Yava, Chandana, Dhanyaka, Amalaki, Vasa, Lavanga, Tvak, Gaja pippli , Haritaki, Madhu, Sita and Ghrita
Dose - 6gm BD before food
Duration - 1 month
Route of Administration - Oral |
| Intervention |
1- Vaman dhauti
2- Shivapalapindi |
1- giving lukewarm saline water and making the patient vomit.
Dose -
Duration -
Route of Administration -
2-Shivapalapindi contains dravyas like Patha, Patola, Yava, Chandana, Dhanyaka, Amalaki, Vasa, Lavanga, Tvak, Gaja pippli , Haritaki, Madhu, Sita,Ghrita
Dose - 6gm BD before food
Duration- 1 month
Route of Administration - Oral |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
-Subjects between the age group of 18 to 40 yrs, irrespective of gender, religion, occupation & socio - economic status.
- Subjects having the Classical symptoms of amlapitta as described in Ayurvedic literature will be included.
|
|
| ExclusionCriteria |
| Details |
- Subjects with any other systemic illness like Hypertension, Diabetes mellitus.
- Previously diagnosed cases of ulceration of stomach, esophagus, and duodenum, CA of G.I tract and crohn’s disease.
- Subjects who are not fit for Vaman dhauti will be excluded.
- Pregnant lady & lactating women will be excluded.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce in the sign and symptoms of Amlapitta |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| other associated symptoms of amlapitta will reduce. |
45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/03/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Amlapitta
is a primary disorder of annavaha strotas, caused by vitiation of
tridoshas which leads to mandagni causing vidagdhajirna which
in turns leads to vidahi condition. It is characterized by avipaka,
klama, tikta-amlodgara, hrud kanta daha, gaurva, aruchi1.The
above symptoms resemble gastric esophageal reflux diseases, which has signs and
symptoms of heart burn, regurgitation, nausea, indigestion2.
The prevalence of GERD in India is
likely to be between 8 - 19% 3. Mostly it is seen in 2nd decade of
life. Several factors like change in lifestyle in terms of culture, smoking and
use of specific food types have contributed to the increased prevalence of GERD
in this rapidly progressing society. Though antacids are the most recommended
treatment in GERD, it is not permanent treatment to cope up with the current
situation. The long term use of antacids can bring side effects including
diarrhoea, constipation, changes in metabolism and build up of magnesium. So, there is need of
evolving more effective treatment which relives human sufferings.
Even though there are hundreds of
medicinal combination are mentioned in the classics for amlapitta, very
few of such medicinal measures are proved by clinical study, hence it is a need
of hour to explore the efficacy of remaining ones.
Vamana dhauti is one among the shadkarma,
which is practiced for the removal of kapha pitta dosha4.
It acts over amasaya, which is the prime seat of amlapitta. It neutralizes
the acid balance in stomach and relives the symptoms.
Shivapalapindi contains dravyas
like Patha, Patola, Yava, Chandana, Dhanyaka, Amalaki, Vasa, Lavanga, Tvak, Gaja pippli , Haritaki,
Madhu, Sita and Ghrita5, which are kapha-pittahara
in nature along with dipana, pachana, anulomana, grahi
properties.
Hence in this study Vamanadhauti
and Shivapalapindi are taken as interventions which may help in reducing
the signs & symptoms of amlapitta.
In this regard the study planned – “To Evaluate
the efficacy of Vamana dhauti
with and without Shivapalapindi in Amlapitta†is being undertaken.
|