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

Phase 2

Not yet recruiting

• Conditions: Acute amebic dysentery, (2) ICD-10 Condition: A069||Amebiasis, unspecified, (3) ICD-10 Condition: K00-K95||Diseases of the digestive system,

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

Brief Summary

This study is  a multicentric open trial in patients with **Zaheer (Dysentery)** After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed clinically at 0,1,2,4,6 weeks.  This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 1 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.

**Composition of** ***SafoofTeen***

| | | |

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

|**S. No.**

**Ingredients**

**Quantity**

|1.

Aspaghol

1 part

|2.

Tukhm-e-Raihan

1 part

|3.

Tukhm-e-Mako

1 part

|4.

Nishasta-e-Gandum

1 part

|5.

Samagh-e-Arabi

1 part

|6.

Gil-e-Armani

1 part

|7.

Tabasheer

1 part

|8.

Tukhm-e-Hammaz Biryan

1 part

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-07-12
• Study Start: 2018-08-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Patients of either sex in the age group 18-65 years.
• Patients of ZahÄ«r (Dysentery) having the following signs and symptoms: (i) 2-8 small-volume, semiformed or unformed stools/day (ii) BarÄz DamwÄ« (Bloody Stools) and/or BarÄz MukhÄtÄ« (Mucoid Stools) (iii) E.
• histolytica Cysts or Trophozoites in stools With or without any of the following: Maghs (Tenesmus) Waja‘ al-Batn Asfal (Lower Abdominal Pain) ĪlÄm al-Batn Asfal (Lower Abdominal Tenderness).

Exclusion Criteria

• 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.
• 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.
• 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)	six weeks

Secondary Outcome Measures

Name	Time	Method
Hematological and biochemical assessments for safety	six weeks

Trial Locations

Locations (3)

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

Regional Research Centre; 🇮🇳 Allahabad, UTTAR PRADESH, India

Regional Research Institute of Unani Medicine; 🇮🇳 Bhadrak, ORISSA, India

Clinical Research Unit

🇮🇳Kurnool, ANDHRA PRADESH, India

Dr M Ramesh

Principal investigator

9642479619

dr_ramesh4u@yahoo.co.in