| CTRI Number |
CTRI/2024/03/063741 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
28/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To assess the effect of Pistacia Lentiscus extract in Patients with Diabetic Gastroparesis |
|
Scientific Title of Study
|
Efficacy of Pistacia Lentiscus plant extract in patients with diabetic gastroparesis –with increased small bowel transit time: A Randomized double
blind control trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RASHI MITTAL |
| Designation |
Junior Resident |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Level 6, OPD block, Department of General Medicine, AIIMS Rishikesh, Rishikesh, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
09686870026 |
| Fax |
|
| Email |
rashimittal1947@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Ravi Kant |
| Designation |
Professor and HOD |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Level 6, College Block, Department of Internal Medicine, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India- 249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9870717859 |
| Fax |
|
| Email |
drkantr2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Ravi Kant |
| Designation |
Professor and HOD |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Level 6, College Block, Department of Internal Medicine, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India- 249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9870717859 |
| Fax |
|
| Email |
drkantr2006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Medicine, AIIMS Rishikesh, Uttarakhand |
|
|
Primary Sponsor
|
| Name |
Dr Rashi Mittal and Dr Ravi Kant |
| Address |
6th floor, OPD block, Department of General Medicine, AIIMS Rishikesh |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 |
| Rashi Mittal |
AIIMS Rishikesh |
Diabetic OPD, Level 2, OPD Block, Department of Internal Medicine, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India- 249203
Dehradun
UTTARANCHAL |
8686870026
rashimittal1947@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee, AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pistacia Lentiscus Plant Extract |
This agent will be given in capsule form 500 mg per orally twice daily dose for 8 weeks time period |
| Comparator Agent |
Placebo |
A similar looking capsule containing inert agents will be given twice daily per orally for a time period of 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 diabetes patients more than 18 years of age and diagnosed as Diabetic gastroparesis with increased small bowel transit time |
|
| ExclusionCriteria |
| Details |
Patients with age less than 18yrs
Patients with any known or clinically suspected organic Gastrointestinal disorder
Patients with history of gastric surgeries
Patient with Irritable bowel syndrome
Patients with delayed Gastric Emptying time.
Patient with using drugs interfering with gastrointestinal motility |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the improvement in GCSI score in patients with increased Small bowel Transit Time with Pistacia lentiscus plant extracts(Chios mastic gum) in comparison with a Placebo drug |
At baseline, 2 weeks, 4 weeks, 6 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To calculate GCSI score pre and post intervention in both groups |
Baseline at 0 weeks then at completion of 8 weeks |
| To Find the proportion of patients having Diabetic Gastroparesis by using GSCI score and Gastric Emptying Scintigraphy |
at the time of screening |
| To find out the change in small intestinal transit time by using pistacia lentiscus plant extract |
AT completion of 8 weeks |
| To find out the effect of mastic gum on Hba1C, blood sugars, lipid profile |
Baseline data compared to data at 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes is a group of metabolic diseases characterized by hyperglycemia due to insulin secretion or action defects. Gastrointestinal neuropathies in patients with diabetes represent vital aspects of the chronic course of the disease. This can be perceived as chronic delayed gastrointestinal emptying associated with nausea, vomiting, postprandial fullness, weight loss, anorexia, and abdominal pain without evidence of mechanical obstruction. Small Bowel Transit is often found to be abnormal in Diabetic patients and may lead to small intestinal bacterial overgrowth. Upto 80% patients with diabetic gastroparesis have abnormal small bowel motility. Traditional treatments for Diabetic Gastroparesis include dietary changes and medication, but severe cases may require surgery or gastric electrical stimulation (GES). Pistacia species extracts suggest alleviating gastrointestinal symptoms, yet no Indian studies support the evidence despite Pistacia plant species being present in the Great Himalayan regions. This study explores the therapeutic potential of Pistacia plants in treating Diabetic Gastroparesis, in a subset of patients with delayed small bowel transit, leveraging their natural antioxidants to enhance gut motility. |