Treatment of Non bleeding piles with Unani Medicine Habb-e-Bawaseer Amya.

Phase 2

Not yet recruiting

• Conditions: First degree hemorrhoids,

• Registration Number: CTRI/2018/08/015373
• Lead Sponsor: Central Council For Research In Unani Medicine

Brief Summary

his study is a multicentric open trial in patients with **Bawaseer Amya (Non bleeding piles)** After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed clinically on Baseline,and after two  weeks.  This includes subjective assessment of general well being and physical examination . The total duration of treatment will be fourteen days. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy

Composition of*Habb-e-Bawaseer Damiya* (Anonymous, 2006)

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

|**S. No.**

**Ingredients**

**Botanical / English Name**

**Quantity**

|

Rasaut

*Berberis aristata* DC.

100 g

|

Halela Kabli Biryan

*Terminalia chebula* Retz.

100 g

|

Raughan Zard

Cow’s Ghee

Q.S.

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: 300

Inclusion Criteria

• Patients of either sex in the age group 18 to 65 years 2.
• Patients diagnosed with BawÄsÄ«r Umiyya (Non-bleeding Piles) presenting with any of the following symptoms: (i) Mucoid Anal/ Perianal Discharge (SayalÄn al-Maq‘ad MukhÄtÄ«): mucus discharge (ii) Pruritus Ani (Hikka al-Maq‘ad) (iii) Mucosal Prolapse (KhurÅ«j al-MukhÄtÄ«yya) with Spontaneous Reduction (iv) Rectal/ Anal Pain (Waja‘ al-Maq‘ad).

Exclusion Criteria

• The following patients will be excluded from the study: 1.
• Patients with Bawaseer Damiya (Bleeding piles).
• Patients with Fourth Degree Haemorrhoids (irreducible prolapse) 3.
• Known cases of Anal fissure, anal fistula and other surgical conditions of the anus.
• Known cases of other clinically significant co-morbid conditions (severe hepatic, renal, cardiovascular disorders, etc) 5.
• Patients with Inflammatory Bowel Disorders (Positive Haemoccult Test) 6.
• Pregnant and Lactating Women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms of Bawaseer Amya (Non bleeding piles)	Two Weeks

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessment	Two weeks

Trial Locations

Locations (2)

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

Regional Research Institute of Unani Medicine; 🇮🇳 Chennai, TAMIL NADU, India

Regional Research Centre

🇮🇳Allahabad, UTTAR PRADESH, India

Dr Ashok Kumar

Principal investigator

9450619024

rrcallahabad@gmail.com