| CTRI Number |
CTRI/2018/02/011875 [Registered on: 13/02/2018] Trial Registered Prospectively |
| Last Modified On: |
28/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Diet Regimen] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of triphala lauha in the patients of Amlapitta( gastric disorders like heartburn,indigestion, nausea etc) |
|
Scientific Title of Study
|
To study the efficacy of triphala lauha in disintegration of aetiopathogenesis of Amlapitta |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Vidula Gujjarwar |
| Designation |
Proffesor |
| Affiliation |
Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar, Najafgarh |
| Address |
Department of Rog Nidan Evum Vikriti Vigyan
Ch. Brahm Prakash Ayurved Charak Sansthan
Khera Dabar
Njafgarh
New delhi
New Delhi
DELHI
110073
India |
| Phone |
9990174348 |
| Fax |
|
| Email |
shreemahalaxmi1969@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Vidula Gujjarwar |
| Designation |
Proffesor |
| Affiliation |
Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar, Najafgarh |
| Address |
Department of Rog Nidan Evum Vikriti Vigyan
Ch. Brahm Prakash Ayurved Charak Sansthan
Khera Dabar
Njafgarh
New delhi
New Delhi
DELHI
110073
India |
| Phone |
9990174348 |
| Fax |
|
| Email |
shreemahalaxmi1969@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Vidula Gujjarwar |
| Designation |
Proffesor |
| Affiliation |
Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar, Najafgarh |
| Address |
Department of Rog Nidan Evum Vikriti Vigyan
Ch. Brahm Prakash Ayurved Charak Sansthan
Khera Dabar
Njafgarh
New delhi
New Delhi
DELHI
110073
India |
| Phone |
9990174348 |
| Fax |
|
| Email |
shreemahalaxmi1969@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ch.Brahm Prakash Ayurved Charak Sansthan
Khera Dabar
Najafgarh
New Delhi 110073 |
|
|
Primary Sponsor
|
| Name |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar Najafgarh New Delhi |
| Type of Sponsor |
Other [State Government Ayurvedic College] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of trog Nidan Evum Vikriti Vigyan |
Ch Brahm Prakash Ayurved Charak Sansthan
Khera Dabar Najafgarh
New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Dr Vidula Gujjarwar |
Ch.Brahm Prakash Ayurved Charak Sansthan Khera Dabar, Najafgarh |
OPD no. 20 and 22 of Rog Nidan and Atayayika vibhag
New Delhi
DELHI |
9990174348
shreemahalaxmi1969@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Ch Brahm Prakash Ayurved Charak Sansthan NCT Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients of Amlapitta disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No Treatment |
Fixed Diet Regimen |
| Intervention |
Triphala Lauha |
250 mg BD for 45 days
Fixed diet Regimen |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex
2. Patients with age group between 25-55 years
3. Patients with symptoms of Amlapitta like Amlaudgara(sour belching)Daha(burning sensation )Chhardi(vomiting) Shoola(pain)
4.Patients having symptoms of Amlapitta for more than 7 days
5.Patients taking modern medicines
|
|
| ExclusionCriteria |
| Details |
1.Patients of age below 25 years and more than 55 years
2.Patients of severe vomiting and dehydration
3.Pregnant women and lactating mother
4.Patients with gastric malignancy
5.Patients having addiction of alcohol
6.Patients who recently undergone gastrointestinal surgery |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in symptoms of amlapitta |
Every 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in symptoms of Amlapitta |
every 15 days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/03/2018 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In today’s life there is continuously change in life style and dietary habits of the people. Most of the people are crazy for junk foods and some, due to their busy schedule do not even bother to take proper diet. In both of the conditions,the body elements vata, pitta and kapha gets vitiated and leads to various disorders, Amlapitta is one among the various gastrointestinal diseases which occurs due to vitiation of pitta dosha. Whenever due to improper digestion amlta of Pitta is increased it leads to Amlapitta disease.Now a days it becomes a worldwide disease and it is increases day by day. There are so many drugs available who works on it but still some more researches are required to get more effective, inexpensive and safe drugs. Triphala lauha is mentioned in chakradutta in Parinam shooladhyaya for the cure of amlapitta disease. Contents of this drug are aamlaki, vibhitaki and haritaki in same proportion. This trial is oriented towards knowing of aetiopathogenesis oand management of Amlapitta.
Assessment Criteria
Subjective improvement will be assessed by adopting suitable scoring methods
Study Type Randomized Comparative Clinical Trial
Intervention time 45 days
Sample Size 60 ( 30 in each group)
Group A Triphala Lauha 250 mg BD and fixed diet regimen
Group B Fixed diet regimen
|