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Study of Mahalakshmi Vilas Ras with standard Treatment in Patients with Headache After Spinal Injection

A Randomized Controlled Clinical Trial to Evaluate the Add on effect of Mahalakshmi Vilas Ras with standard treatment in the Management of Post-Spinal Headache - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/107704
Enrollment
66
Registered
2026-04-07
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: G970- Cerebrospinal fluid leak from spinal puncture

Interventions

None listed

Sponsors

R A Podar Ayurvedic Medical College Worli
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 20-50 years. 2. Diagnosis: Clinically confirmed Post-Spinal Headache (PSH) based on ICHD -3 Criteria 3. Patient must undergone : Spinal anesthesia or lumbar puncture within 72 hrs 4. Symptom Onset: Headache onset within 72 hrs post-procedure 5. Health Status: Hemodynamically stable; no urgent neuro/systemic illness. 6. Gender: Both males and females eligible.

Exclusion criteria

Exclusion criteria: 1. Allergy: Known allergy to Mahalakshmi Vilas Ras or its ingredients. 2. Pregnancy/Lactation: Pregnant or breastfeeding women. 3. Severe Illness: such as uncontrolled diabetes, cardiac, hepatic, or renal disease. 4. Other Headaches: Chronic migraine, meningitis, or other CNS pathology,sinusitis,headache due to refractive errors,headache due to cervical spondylosis 5. Vital Instability: Unstable vitals or signs of systemic infection. 6. Substance Abuse: History of alcohol abuse or drug abuse.

Design outcomes

Primary

MeasureTime frame
1.Reduction in severity of post-spinal headache in patients receiving Mahalakshmi Vilas Ras with standard treatment compared to those receiving standard treatment alone. 2.effect of Mahalakshmi vilas ras as an add on to standard treatment in reducing giddiness compared to standard treatment alone in PSH Timepoint: 3 DAYS

Secondary

MeasureTime frame
1.Effect of Mahalakshmi vilas ras as an add on to standard treatment in reducing nausea and vomiting compared to standard treatment alone in PSH Timepoint: 3 DAYS

Countries

India

Contacts

Public ContactDr Madhuri Bhandare

R A Podar Ayurvedic Medical College,Worl

bhandare_madhuri@yahoo.co.in09960108635

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026