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Efficacy of UNANI formulation in IRRITABLE BOWEL SYNDROME

Efficacy of safoof e chahar tukhm in Irritable bowel syndrome -A Randomized double Blind placebo Controlled Clinical Trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099210
Enrollment
34
Registered
2025-12-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: K582- Mixed irritable bowel syndrome

Interventions

Intervention1: Safoof e chahar tukhm: Aspaghol (Plantago ovata Forsk.) Tukhm e Kanocha (Phyllanthus maderaspatensis Linn.) Tukhm e Rehan (Ocimum basilicum) Tukkhm e Bartang (Plantago major Linn.) : T

Sponsors

National Institute of Unani Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged between 18-65 years of any gender Clinically diagnosed cases of IBS according to Rome 4 criteria and mild to moderate cases [74 to 299 score]according to IBS-SSS Patients who are willing to give consent and complete the trial documentation ROME 4 criteria Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria: Related to defecation pain, it may be increased or unchanged by defecation. Associated with a change in the frequency of stool Associated with a change in the form (appearance) of stool Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis

Exclusion criteria

Exclusion criteria: Patients below 18 years and above 65 years IBS diagnosed with IBS-SSS Score more than 300 Patients who are known cases of Renal, Cardiac, Liver and Pulmonary diseases. Pregnant and Lactating females Patient with uncontrolled Hypertension (SBP more than 140 mm of Hg, DBP more than 90 mmHg, in patients on anti-hypertensive medications) Patients with uncontrolled Diabetes Mellitus (RBS more than 200MG per dl, in patients on hypoglycaemic medications). GIT diseases like GERD, pancreatitis, history of colon and rectal cancer, intestinal TB, Ulcerative colitis or crohns diseases, Anemia, Malena. History of GIT surgeries. Subjects who are using antibiotics, symbiotics, antispasmodics, Laxatives, anticholinergic for the last four week [prior to enrolment]

Design outcomes

Primary

MeasureTime frame
Reduction in symptoms score assessed using IBS- SSS QuestionnairesTimepoint: 0th, 15th, 30th and 45th days

Secondary

MeasureTime frame
Improvement in quality-of-life Questionnaires [IBS-QOL or quality of life] subjective parameters abdominal pain and bloating will be assessed by Dichotomous scale ( Present and Absent) and frequency of stools in numbers and consistency of stool will be assessed by Bristol scale. Timepoint: 0th and 45th days

Countries

India

Contacts

Public ContactDr Mohd Riyazuddin

National Institute of Unani Medicine

shaikh.riyaz368@gmail.com8010392768

Outcome results

None listed

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