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To evaluate the effect of Laxirid syrup in the management of constipation

An open comparative randomized clinical studyto evaluate the efficacy of JLN/PP/107 an herbal laxativein the management of functional Constipation

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/012110
Enrollment
60
Registered
2018-02-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: K590- Constipation

Interventions

Intervention1: Laxirid Syrup: Laxirid Syrup is an Ayurvedic syrup consists of Trivrit & yashtimadhu. Both these ingredients are useful in treatment of constipation as per the classical literature.Laxi

Sponsors

Dabur India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects presenting with two or more of the following for at least 12 weeks ( not necessary consecutive) in the preceding 12 months (the Rome II criteria): 1.1 Straining at defecation more than 25% of bowel movements 1.2 Lumpy or Hard Stools more than 25% of bowel movements 1.3 Sensation of incomplete evacuation for more than 25% of bowel movements 1.4 Sensation of ano-rectal blockage for more than 25% of bowel movements 1.5 Manual maneuvers two facilitate more than 25% of bowel movements 1.6 less than 3 bowel movements per week. 2. Willingness to sign informed consent and to come for regular follow up examinations as & when required.

Exclusion criteria

Exclusion criteria: 1.Patient with diagnosed colonic inertia. 2.Patients with history of ano rectal surgery. 3.Patients with structural abnormalities, like: 3.1 Ano rectal: rectal prolapsed, rectocele, rectal intussuception, anorectal stricture, solitary rectal ulcer syndrome. 3.2 Perineal descent 3.3 Colonic/ rectal mass or tumor with obstruction e.g. adenocarcinoma 3.5 Colonic stricture; radiation, ischemia, diveticulosis 3.6 Hirschsprungâ??s disease 3.7 Idiopathic megarectum 3.8 Intestinal obstruction 4.Patients with diagnosed neurological problems like,Parkinsonâ??s disease, Multiple Sclerosis Sacral nerve damage (prior pelvic surgery, tumor),Paraplegia,Autonomic neuropathy. 5.Patients with serious systemic ailments like HIV, DM and tuberculosis 6.Pregnant or lactating females 7.Patient with renal or liver dysfunction 8.Patient not willing to sign informed consent 9.Patient not willing to come for follow up when required 10.Patient on chronic medication (more than 60 days) and/or who are on medications known to cause constipation.

Design outcomes

Primary

MeasureTime frame
Any improvement or relief from clinical symptoms related to the acidity or by the resolution of symptoms which ever stands earlyTimepoint: At the end of 2 weeks and 4 weeks

Secondary

MeasureTime frame
The clinical global response by physician and the subject in overall improvementTimepoint: At the end of study

Countries

India

Contacts

Public ContactDr J L N Sastry

Sri Jayendra Saraswati Ayurvedic Medical college

lnsjata@yahoo.com8587076669

Outcome results

None listed

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