| CTRI Number |
CTRI/2017/09/009797 [Registered on: 15/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
18/03/2017 |
| 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
|
Comparision of two drugs , Madanphala and Jeemutaka in the patients of Amlapitta (non-ulcer Dyspepsia) by Vamana(therapeutic emesis) |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF VAMANA KARMA BETWEEN MADANPHALA AND JEEMUTAKA 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 |
Rajni Sharma |
| Designation |
Student |
| Affiliation |
Bharati Vidyapeeth Deemed University College of Ayurved Dhankawdi Pune-43 |
| Address |
Bharati Vidyapeeth Deemed University College of Ayurved Dhankawdi Pune-43
Maharashtra
Bharati Vidyapeeth Deemed University College of Ayurved Dhankawdi Pune-43
Maharashtra
Pune
MAHARASHTRA
411043
India |
| Phone |
7507373663 |
| Fax |
|
| Email |
rajnisharma.oct@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajni Sharma |
| Designation |
Student |
| Affiliation |
Bharati Vidyapeeth Deemed University College of Ayurved Dhankawdi Pune-43 |
| Address |
Bharati Vidyapeeth Deemed University College of Ayurved Dhankawdi Pune-43
Maharashtra
Bharati Vidyapeeth Deemed University College of Ayurved Dhankawdi Pune-43
Maharashtra
Pune
MAHARASHTRA
411043
India |
| Phone |
7507373663 |
| Fax |
|
| Email |
rajnisharma.oct@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santosh E Chavan |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth Deemed University College of Ayurved Dhankawdi Pune-43 Maharashtra |
| Address |
Bharati Vidyapeeth Deemed University College of Ayurved Dhankawdi Pune-43
Maharashtra
Bharati Vidyapeeth Deemed University College of Ayurved Dhankawdi Pune-43
Maharashtra
Pune
MAHARASHTRA
411043
India |
| Phone |
9822249807 |
| Fax |
|
| Email |
dr_chavan@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed University College of Ayurved Dhankawdi Pune Maharashtra |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth Deemed University College of Ayurved Dhankawdi Pune Maharashtra |
| Address |
Bharati Vidyapeeth Deemed University College of Ayurved Dhankawdi Pune-43
Maharashtra
|
| 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 |
| Rajni Sharma |
Bharati Vidyapeeth Ayurvedic Hospital |
Bharati Vidyapeeth Ayurvedic Hospital,
Panchakarma Department,3rd floor.
Pune
MAHARASHTRA |
7507373663
rajnisharma.oct@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati vidyapeeth deemed university, college of ayurved, pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients suffering from Amlapitta, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jeemutaka |
Group B - Vamana with Jeemutaka decoction |
| Comparator Agent |
Madanphala |
Group A - vamana with Madanphala decoction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having symptoms like Chardi, tiktaamla udgara, avipaka, utklesha, kantha daha, hrud daha
2. patients between age group 18-60yrs
3. patients of either sexes |
|
| ExclusionCriteria |
| Details |
1.Patients with complications like cardiac problems, emphysema, carcinoma etc.
2. pregnant women and lactating mothers
3. patients above 60yrs and below 18yrs. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The effects of the Madanphala and Jeemutaka as Vamakadravya in Amlapitta.
|
Same Day (0 day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in the signs and symptoms of Amlapitta |
on 15th day and 30th day from the date of Vamana |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
17/09/2016 |
| 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="8"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
In process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Amlapitta is more of a psycho somatic disorder caused due to dietetic indiscrimination and mental stress and strain
Amlapitta is a Pitta pradhana disease of the Annavaha Stotas caused due to Mandagni, Ama and Annavaha Sroto Dusti. It is characterized by Amlodgara, Utklesha and Hrtkanta daha indicating the vikruthi of Pachakapitta along with the Kledaka kapha and Samana Vayu
Acarya Yogaratnakar emphasized Vamana Therapy in Amlapitta Chikitsa. The general principle is to do Vamanaa, if the doshas are sited in urdhwa amashaya Bhavamishra advised Vamanaa. (Urdhwaga Amlapitta )and Virechana in Adhoga Amlapitta
The main objective of treatment in Amlapitta is to expell the doshas from nearest route. i.e. by Vamana and Virechana
Moreover There are number of Madanphala preparations for Vamana .It clearly shows that Madanphala is widely used for medicated Emesis, but there are certain other Vamaka dravya which are equally effective in different diseases. While studying further for specific conditions or diseases specific Vamaka dravya are indicated.So unexplored Vamaka dravya should be addressed in proper clinical trial,it’s a need of our study.
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