Treatment of Severe pain in head with Unani medicine Habb-e-Mujarrrib

Phase 3

Not yet recruiting

• Conditions: Migraine, unspecified,

• Registration Number: CTRI/2024/10/076028
• Lead Sponsor: Central Council for Research in Unani Medicine CCRUM New Delhi

Brief Summary

This study is designed as a multi centric open trial in patients with **Shaqeeqa (Migraine)**. After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed clinically at every 2 weeks for 12 weeks. This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 12 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.

**Composition of****Habb-e-Mujarrib:**

| | | | |

| --- | --- | --- | --- |

|**S. No.**

**Ingredients**

**Botanical Name**

**Quantity**

|1.

*Sibr*

*Aloe barbadensis miller*

1 g

|2.

*Chiraita sheeren*

*Swertia chirata*

2 g

|3.

*Jauzbuba*

*Myristica fragrans*

2 g

|4.

*Zeera safed*

*Cuminum cyminum*

3 g

|5.

*Tukhm e karafs*

*Apium graveolens L*

3 g

|6.

*Aab e kundush*

*Centipeda minima*

Q.S.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-10-29
• Study Start: 2024-11-11

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Patients of either gender in the age group 18- 65 years 2.
• Primary diagnosis of Migraine without aura by ICHD-3 beta as follows: A.
• At least five attacks fulfilling criteria B–D.
• Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated).
• Headache has at least two of the following four characteristics: Unilateral location Pulsating quality Moderate or severe pain intensity Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs).
• During headache at least one of the following: Nausea and/or vomiting.
• Photophobia and phono phobia.
• Not better accounted for by another ICHD-3 diagnosis.

Exclusion Criteria

• Known case of any structural brain abnormalities 2.
• Known case of Ocular disease 3.
• History of Ischemic stroke 4.
• Any disease involving sinus e.g. Rhinosinusitis 5.
• Systemic illness requiring long term treatment 6.
• Known cases of Chronic kidney & liver disease 7.
• Known cases of Psychiatric illness 8.
• Difficulty distinguishing migraine headache from other headaches 9.
• Known cases of Epilepsy and other neurological disorders 10.
• History of alcohol and drug abuse.
• Pregnancy & lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The efficacy of the study drug will be assessed on the basis of clinical parameters based on grading of symptoms, scoring of MIDAS and any change in rescue medication pattern.	At baseline and at every two weeks till the completion of the trial i.e. upto 12 weeks

Secondary Outcome Measures

Name	Time	Method
Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination	At baseline and at the end of treatment i.e. 12 weeks

Trial Locations

Locations (2)

Clinical Research Unit; 🇮🇳 Kurnool, ANDHRA PRADESH, India

Regional Institute of Unani Medicine (RRIUM); 🇮🇳 Aligarh, UTTAR PRADESH, India

Clinical Research Unit

🇮🇳Kurnool, ANDHRA PRADESH, India

Dr Jawadul Haq

Principal investigator

9502443555

cru.kurnool@gmail.com