To evaluate the Safety and efficacy of a Unani formulations in the treatment of Zahīr (Dysentery)
- Conditions
- Health Condition 1: A060- Acute amebic dysentery
- Registration Number
- CTRI/2015/12/006431
- Lead Sponsor
- Central Council for Research in Unani Medicine New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 300
•Patients of either sex in the age group 18-65 years.
•Patients of ZahÄ«r (Dysentery) having the following signs and symptoms:
ï?§2-8 small-volume, semiformed or unformed stools/day
ï?§BarÄ?z DamwÄ« (Bloody Stools) and/or BarÄ?z MukhÄ?tÄ« (Mucoid Stools)
ï?§E. histolytica Cysts or Trophozoites in stools
With or without any of the following:
ï?§Maghs (Tenesmus)
ï?§Wajaâ?? al-Batn Asfal (Lower Abdominal Pain)
ï?§ÄªlÄ?m al-Batn Asfal (Lower Abdominal Tenderness)
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 signs and symptoms of Zimad e Bars of Zahīr (Dysentery)Timepoint: 2 weeks
- Secondary Outcome Measures
Name Time Method Haematological and biochemical assessment for safety assessmentTimepoint: 2 weeks