| CTRI Number |
CTRI/2025/07/091670 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Type 2 Diabetic patients with constipation are compared with Pistacia lentiscus against Prucalopride to see the improvement in terms of colon transit time and improvement is Gastrointestinal Symptoms Relief Score |
|
Scientific Title of Study
|
Efficacy of Pistacia lentiscus plant extract (Mastic gum) in comparison to Prucalopride in Type 2 diabetic patients with constipation- A randomized open label controlled 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 |
Vinoth C |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Level 6, Department of Internal Medicine, AIIMS Rishikesh, Veerbhadra Marg, Shivaji Nagar, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9487792669 |
| Fax |
|
| Email |
cvinoth@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Darab Singh |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Level 6, Department of Internal Medicine, AIIMS Rishikesh, Veerbhadra Marg, Shivaji Nagar, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9828676359 |
| Fax |
|
| Email |
drdrbsingh2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinoth C |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Level 6, Department of Internal Medicine, AIIMS Rishikesh, Veerbhadra Marg, Shivaji Nagar, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9487792669 |
| Fax |
|
| Email |
cvinoth@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vinoth C |
| Address |
Level 4, Department of Internal Medicine, AIIMS Rishikesh, Veerbhadra Marg, Shivaji Nagar, Rishikesh
PIN: 249203 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Vinoth C |
AIIMS Rishikesh |
Level 6, Department of Internal Medicine, AIIMS Rishikesh, Veerbhadra Marg, Shivaji Nagar, Rishikesh
Dehradun
UTTARANCHAL |
09487792669
cvinoth@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional 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 |
Pistacia lentiscus will be given for a period of 4 weeks(500 mg PO BD) |
| Comparator Agent |
Prucalopride |
Prucalopride will be given for 4 weeks (2mg PO OD) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Type 2 Diabetes Mellitus with constipation satisfying
Rome IV Criteria.
• Age 18-60 Years |
|
| ExclusionCriteria |
| Details |
1. Pregnancy and Lactating Mothers
2. Allergy to egg/ any component of meal taken before the nuclear scan
3. Known organic gastrointestinal disorder
4. History of gastrointestinal surgery
5. On drugs interfering gastrointestinal motility like prokinetics, domperidone, tricyclic antidepressants, thyroxine, anti-thyroid drugs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the improvement in CTT (colon transit
time) and GSRS (Gastrointestinal Symptom Rating
Scale) in diabetic patients with constipation among
those receiving Pistacia lentiscus extracts (group1)
and prucalopride (group2) |
At baseline
4 weeks after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To monitor side effects & compliance with Pistacia lentiscus extract & Prucalopride |
At baseline
4 weeks after intervention |
| 2. To compare the improvement in GSRS (Gastrointestinal Symptom Rating Scale) score & correlate it with improvement in colon transit time |
At baseline
4 weeks after intervention |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
11/08/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [cvinoth@hotmail.com].
- For how long will this data be available start date provided 23-07-2026 and end date provided 23-07-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Gastrointestinal
manifestations in type 1 and 2 diabetes are common and represent substantial causes
of morbidity and health care costs as well as diagnostic and therapeutic
challenge. Prucalopride, a
selective serotonin agonist has been proved to have effect in both colon
transit time as well as gastric emptying time and is an approved drug for
constipation and is used in diabetic gastrointestinal neuropathies. There are some tolerable
side effects of this drug in chronic use. Because of this, there is a need to find a drug,
which can help to improve gastroparesis symptoms with sustainable effects. Mastic
gum is not only a natural product with minimum or no side effects but also
easily acceptable for most geriatric as well as younger diabetic population. Currently patients are being screened. Eligible patients will be recruited after obtaining clearance. |