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A Pilot Study to Evaluate the Effect of Safuf-e-Banafsha Tea Bags in Patients with Gastric Headache

Clinical Evaluation of Safuf-e-Banafsha Tea Bags in Suda Shirki Midi (Gastric Headache): A Pilot Study on Gut Brain Axis Modulation - GH

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103646
Enrollment
10
Registered
2026-02-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: G448- Other specified headache syndromes

Interventions

Intervention1: Safuf e Banafsha Tea bags: Formulation:Safuf-e-Banafsha Tea Bags containing: -Banafsha (Viola odorata) : 4 parts -Gul-e-Surkh (Rosa damascena) : 2 parts -Kishniz-e-Khushk (Coriandrum sa

Sponsors

CCRUM
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 60 years diagnosed with Suda Shirki Midi(gastric headache)based on classical Unani criteria. 2.Experiencing recurrent headache episodes attributed to gastric disturbances. 3.Headache severity and frequency significant enough to impact daily activities. 4.Headache presenting with at least two of the following characteristics: .Frontal or upper abdominal referral .Pulsating or pressure-type quality .Moderate to severe intensity .Worsening with routine activity (e.g., head movement, bending) 5.During headache, if there is : .Gastrointestinal discomfort (nausea, vomiting, bloating) .Photophobia or Phonophobia 6.Able and willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Secondary headaches due to neurological, systemic, or psychiatric disorders. 2.Major medical illness under treatment. 3. Pregnant or lactating women. 4.Known allergy to any ingredients ofSafuf -e-Banafsha Tea bags. 5.History of alcohol & drug abuse . 6.Use of any other alternative medication during study period. 7.Patients with baseline VAS score greater than 7

Design outcomes

Primary

MeasureTime frame
Improvement in the sign, symptoms and Reduction in number of headache days per week ( from baseline to week 8 )Timepoint: Baseline (Day 0), Week 2, Week 4, Week 6, Week 8.

Secondary

MeasureTime frame
1. Headache characteristics: Intensity: Reduction in headache intensity as measured by Visual Analogue Scale (VAS, 0 10).[17,18] .Frequency & Duration: Decrease in frequency and total duration of headache episodes recorded in headache diary. 2. Gastrointestinal symptoms: Change in gastric symptoms (nausea,pain, bloating, dyspepsia) measured by Gastrointestinal Symptom Rating Scale (GSRS). [19,20] 3. Evaluation of hematological and biochemical parameters (CBP, LFT, RFT, CRP) for safety before and after treatment.Timepoint: Baseline (Day 0), Week 2, Week 4, Week 6, Week 8.

Countries

India

Contacts

Public ContactMubeen

Government Nizamia Tibbi College

itsmemubeen01@gmail.com8125766004

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026