Treatment of Cerebro-asthenia by Unani medicine HabbeJadwar Kochak

Phase 3

Not yet recruiting

• Conditions: Other specified nonpsychotic mental disorders,

• Registration Number: CTRI/2020/07/026544
• Lead Sponsor: Central Council for Research in Unani Medicine CCRUM New Delhi

Brief Summary

This study is designed as a multicentric open trial in patients with **Ḍu‘f al-DimÄgh (Cerebro-asthenia)****.**After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed clinically at every week. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 6 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.

Composition of**Habb e Jadwar Kochak**

| | | | |

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

|**S. No.**

**Ingredients**

**Botanical Name**

**Quantity**

|1.

Jadwar

*Delphinium denudatum* Wall.

10 g

|2.

Banafsha

*Viola odorata*

10 g

|3.

Zafran

*Crocus sativus*

10 g

|4.

Ambar Ash-hab

*Ambra grasea*

5 g

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-18
• Last Update Posted: 2020-09-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• The patients fulfilling the following criteria will be included in this study: 1.
• Patients of either sex in the age group 40-65 years.
• Patients of Ḍu‘f al-DimÄgh (Cerebro-asthenia) having subjective complaints of cognitive impairment: a.
• Memory loss b.
• Mild headache c.
• ButlÄn-i-Takallum (Speech impairment) e.
• ButlÄn-i-TahrÄ«r (Writing impairment) 3.
• MMSE score of 10-23 representing mild to moderate cognitive impairment.

Exclusion Criteria

• The patients having any of the following criteria will be excluded from the study: 1.
• Clinical presentation and/or history of any significant organic neurological diseases including space occupying lesions, stroke, head injury, seizure, and mental retardation.
• Secondary causes of dementia including hypothyroidism or hyperthyroidism.
• Known cases of B12 vitamin deficiencies.
• Clinical presentation and known case of a chronic disease that requires long-term treatment.
• Patients on Psychotropic Drugs 6.
• H/o alcohol or substance abuse or dependence.
• H/o Hypersensitivity to the study drug or any of its ingredients 8.
• Pregnant and lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in sign and symptoms of Ḍu‘f al-DimÄgh (Cerebro-asthenia)	6 Weeks

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessment	Investigations will be done at baseline and after every two weeks

Trial Locations

Locations (2)

Central Research Institute of Unani Medicine (CRIUM); 🇮🇳 Lucknow, UTTAR PRADESH, India

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

Central Research Institute of Unani Medicine (CRIUM)

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Najmus Sehar

Principal investigator

7903422298

nsehar.ccrum@gmail.com