Effect of Unani medicine Habb-e-Bawaseer Damiya in Bleeding Piles

Phase 2

Completed

Conditions: Other hemorrhoids,

Registration Number: CTRI/2018/10/016190

Lead Sponsor: Central Council for Research in Unani Medicine

Brief Summary: This study is designed as a multicentric open trial in patients with **BawÄsÄ«r DÄmiya (Bleeding Piles)** After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on Baseline and of treatment. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be two weeks. 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)

| | | | |

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

|**S. No.**

**Ingredients**

**Botanical / English Name**

**Quantity**

|1.

Muqil

*Commiphora mukul* (Hook. ex Stocks) Engl.

30 g

|2.

Rasaut

*Berberis aristata* DC.

10 g

|3.

Kahruba

*Pinus succinifera* Linn.

5 g

|4.

Dana Heel Khurd

*Elettaria cardamomum* (Linn.) Maton

5 g

|5.

Damm-ul-Akhwain

*Dracaena cinnabari* Balf.f.

5 g

|6.

Halela Siyah Biryan

*Terminalia chebula* Retz.

5 g

|7.

Amla Khushk

*Phyllanthus emblica* Linn.

5 g

|8.

Tabasheer

*Bambusa arundinacea* (Retz.) Roxb.

5 g

|9.

Gil-e-Armani

Armenian Bole

5 g

|10.

Aab-e-Gandana

*Asphodelus tenuifolius* Cav.

Q.S.

|11.

Raughan Zard

Cowâ€™s Ghee

Q.S.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 300

Inclusion Criteria

Patients of any sex in the age group 19 to 65 years 2.
Patients with a diagnosis of First and Second Degree Hemorrhoids presenting with any of the following symptoms: 3.Bleeding Per Rectum (JarayÄn al-Dam fiâ€™l Maqâ€˜ad): bright-red, painless bleeding 4.
Mucoid Anal/ Perianal Discharge (SayalÄn al-Maqâ€˜ad MukhÄtÄ«): mucus discharge 5.
Pruritus Ani (Hikka al-Maqâ€˜ad) 6.
Mucosal Prolapse (KhurÅ«j al-MukhÄtÄ«yya) with Spontaneous Reduction 7.
Rectal/ Anal Pain (Wajaâ€˜ al-Maqâ€˜ad): on prolapse.

Exclusion Criteria

1.Third & Fourth Degree Haemorrhoids, anal fissure, anal fistula, IBD, Diabetes Mellitus 2.Known cases of other clinically significant co-morbid conditions (severe hepatic, renal, cardiovascular disorders, etc.) that in the opinion of the investigator could affect the efficacy and safety outcome of the study 3.Patients with laboratory values outside the normal limits or those with values considered abnormal in the opinion of the investigator 4.Known hypersensitivity to study drug or any of its ingredients 5.History of alcohol and drug abuse 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 BawÄsÄ«r DÄmiya (Bleeding Piles)	2 weeks

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessment	At baseline and after two weeks

Trial Locations

Locations (2): Clinical Research Unit
🇮🇳
Kurnool, ANDHRA PRADESH, India
Regional Research Institute of Unani Medicine
🇮🇳
Kolkata, WEST BENGAL, India
Clinical Research Unit
🇮🇳Kurnool, ANDHRA PRADESH, India
Dr Jawadul Haq
Principal investigator
09542443555
cru.kurnool@gmail.com