| CTRI Number |
CTRI/2016/07/007095 [Registered on: 13/07/2016] Trial Registered Retrospectively |
| Last Modified On: |
17/07/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
The Study to assess the efficacy of Guava leafs decoction for treating diarrhoea patients. |
|
Scientific Title of Study
|
Documenting the Efficacy of Guava (Psidium guajava) leaf decoction for treating patients with Diarrhoea. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Verison 2 dated 30.04.2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr G Geetha Krishnan |
| Designation |
Senior Consultant |
| Affiliation |
Medanta The Medicity |
| Address |
Medanta The Medicity,
Sector-38
Sec-38,Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
9311193090 |
| Fax |
|
| Email |
g.krishnan@medanta.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Geetha Krishnan |
| Designation |
Senior Consultant |
| Affiliation |
Medanta The Medicity |
| Address |
Medanta The Medicity,
Sector-38
Sec-38,Gurgaon
HARYANA
122001
India |
| Phone |
9311193090 |
| Fax |
|
| Email |
g.krishnan@medanta.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Geetha Krishnan |
| Designation |
Senior Consultant |
| Affiliation |
Medanta The Medicity |
| Address |
Medanta The Medicity,
Sector-38
Sec-38,Gurgaon
HARYANA
122001
India |
| Phone |
9311193090 |
| Fax |
|
| Email |
g.krishnan@medanta.org |
|
|
Source of Monetary or Material Support
|
| The Foundation for Medical Research.
84A,R.G,Thadani Marg,Worli,Mumbai,400018,Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
he Foundation for Medical Research |
| Address |
84A,R.G,Thadani Marg,Worli,Mumbai,400018,Maharashtra,India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Medanta The Medicity |
Sec-38,Gurgaon,Haryana-122001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Geetha K Krishnan |
Medanta The Medicity |
Medanta Institute of Integrative Medicine,Fourth Floor,Room No-25,Medanta The Medicity
Gurgaon
HARYANA |
9311193090
g.krishnan@medanta.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diarrhoea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
The patient will receive standard allopathic treatment including oral rehydration,antiboitics,antimotility drugs,antiacidity drugs,antispasmodic and anti pyretics as required |
| Intervention |
Group 1 |
Boiling 1gm in 120ml until the amount is reduced to 30ml,Each patient would receive 30ml per day in 3 divided doses. |
| Intervention |
Group 2 |
Boiling 3.2gm in 120ml until the amount is reduced to 30ml.Each patient would receive 30ml per day in 3 divided doses. |
| Intervention |
Group 3 |
Boiling 5.3gm in 120ml until the amount is reduced to 30ml.Each patient would receive 30ml per day in 3 divided doses |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults age 18-65 years presenting with the acute Infectious diarrhoea of more than 2 days duration.
Patient with uncomplicated hypertension and diabetes |
|
| ExclusionCriteria |
| Details |
Adults below 18 years and above 65 years of age will be excluded.
Pregnant and lactating women
Non Ambulatory patient
Patient with antibiotic related diarrhoea
Patient with diarrhoea suspected to be caused by food related allergy.
Patient Currently on anti diarrhoeal treatment or severly dehydrated.
Patient who have taken laxatives upto 72 hours prior to reporting.
Patient with any non gastro intestinal complications including previous G.I Surger.
Patient with non chronic medical problem related to liver,kidney and heart with abnormal value based on investigations done. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Control of diarrhoea
2. The Efficacy of the guava decotion in the treatment of infectious diarrhoea ,compared to standard allopathic treatment.
3.The appropriate dose of decoction to be used for treatment of patient with infectious diarrhoea |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Side Effects of the guava leaf decoction
2.The order in which the symptoms get resolved would give an indication of the possible efficacy of the decoction for the treatment of physiological diarrhoea. |
18 months. |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
09/07/2016 |
| Date of Study Completion (India) |
30/03/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will undertake a proof of concept clinical trial with guava leaf decoction to confirm its antidiarrhoeal activity previously demonstrated using in vitro and in vivo assays. This study will not only provide evidence for efficacy but also provide the information regarding doses to be used in the formaulation and the sample size for future multi centric double blind clinical trials,Additionally the evidence generated from this trial is crucial to generate confidence which will allow Foundation of Medical research to access funding for development for a formulation and to collaborate with industry for its manufacture and distribution. |