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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

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091670
Enrollment
60
Registered
2025-07-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: Pistacia lentiscus: Pistacia lentiscus will be given for a period of 4 weeks(500 mg PO BD) Control Intervention1: Prucalopride: Prucalopride will be given for 4 weeks (2mg PO OD)

Sponsors

Vinoth C
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Type 2 Diabetes Mellitus with constipation satisfying Rome IV Criteria. Age 18-60 Years

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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)Timepoint: At baseline 4 weeks after intervention

Secondary

MeasureTime frame
1. To monitor side effects & compliance with Pistacia lentiscus extract & PrucaloprideTimepoint: 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 timeTimepoint: At baseline 4 weeks after intervention

Countries

India

Contacts

Public ContactVinoth C

AIIMS, Rishikesh

drdrbsingh2@gmail.com9828676359

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026