Effect of Unani Medicine Safoof-e-Teen in Zaheer (Dysentery)

Phase 2

• Conditions: Health Condition 1: A060- Acute amebic dysenteryHealth Condition 2: A069- Amebiasis, unspecifiedHealth Condition 3: K00-K95- Diseases of the digestive system

• Registration Number: CTRI/2018/08/015400
• Lead Sponsor: Central Council For Research In Unani Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients of either sex in the age group 18-65 years.

2. Patients of Zahīr (Dysentery) having the following signs and symptoms:

(i) 2-8 small-volume, semiformed or unformed stools/day

(ii) BarÄ?z DamwÄ« (Bloody Stools) and/or BarÄ?z MukhÄ?tÄ« (Mucoid Stools)

(iii) E. histolytica Cysts or Trophozoites in stools

With or without any of the following:

Maghs (Tenesmus)

Wajaâ?? al-Batn Asfal (Lower Abdominal Pain)

ĪlÄ?m al-Batn Asfal (Lower Abdominal Tenderness)

Exclusion Criteria

1. Patients having diarrhoea with >8 stools/day

2. Moderate or severe dehydration

3. Fever (>=101 °F)

4. Patients having amoebic dysentery with any associated severe complications, e.g., fulminant colitis with perforation, paralytic ileus, toxic megacolon, ameboma, and liver abscess.

5. Clinical evidence of coexisting acute systemic illnesses

6. History or clinical evidence of chronic diseases requiring long-term treatment, e.g., DM, hypertension, tuberculosis, HIV infection, chronic liver disease, CKD, coeliac disease, IBD, or any other serious and/or unstable medical condition that, in the opinion of the investigator, could constitute a risk when taking study drug or could interfere with the interpretation of data.

7. Pregnant and lactating women

8. H/o Addiction (alcohol, drugs)

9. H/o Hypersensitivity to the study drug or any of its ingredients

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in sign and symptoms of Safoof-e-Teen in Zaheer (Dysentery)Timepoint: six weeks

Secondary Outcome Measures

Name	Time	Method
Hematological and biochemical assessments for safetyTimepoint: six weeks