Treatment of Bleeding piles with Unani medicine Majoon Teewaj

Phase 3

Not yet recruiting

Lead Sponsor: Central Council for Research in Unani Medicine CCRUM New Delhi

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 treated with Unani pharmacopoeial formulation Majoon Teewaj 5gm twice daily for 42 days. The patients will be assessed clinically at days 14th, 28th and 42nd day. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 42days. Laboratory parameters for safety assessment will be conducted at baseline, 14th day and on completion of the protocol therapy.

Composition of*Majoon-e-Teewaj*

| | | | |

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

|**S. No.**

**Ingredients**

**Botanical /Scientific Names**

**Quantity**

|1.

*Teewaj-e-Khatai*

*Holarrhena antidysenterica* L. *Wall.*

1 Kg

|2.

*Bekh-e-Anjabar*

*Polygonum bistorta* L.

240 g

|3.

*Tabasheer*

*Bambusa arundinaceae* R.

240 g

|4.

*Damm-ul- Akhwain*

*Dracaena cinnabari* Balf. f.

240 g

|5.

*Gil-e-Armani*

Armenian bole

240 g

|6.

*Kateera*

*Cochlospermum religiosum* L. *Alston.*

240 g

|7.

*Gul-e-Nilofar*

*Nelumbo nucifera* Gaertn.

240 g

|8.

*Qand safaid*

*Granular sugar*

7.5 Kg

Recruitment & Eligibility

Inclusion Criteria

Patients of either gender in the age group of 18-65 years 2.
Patients having Rectal bleeding with two or more of the following symptoms of Bleeding Piles Constipation Mucus discharge Rectal fullness or discomfort Anal Itching 3.
Patients of Rectal bleeding diagnosed / confirmed by proctoscopy examination.

Exclusion Criteria

Patients below 18 & above 65 years of age 2.
Advanced hemorrhoids requiring surgery i.e. 3rd & 4th degree hemorrhoids 3.
Patients with anal fissure and fistula in-ano 4.
Patients with rectal prolapse, rectal polyp and palpable abdominal mass 5.
Known cases of Carcinoma, Inflammatory Bowel Disease (Ulcerative colitis, Crohnâ€™s disease etc.) 6.
Known cases of Anaemia, uncontrolled Diabetes mellitus, Chronic hepatic, renal or cardiac ailments 7.
History of long-term medication 8.
History of drug addiction 9.
Pregnancy and lactation.

Primary Outcome Measures

Name	Time	Method
Improvement in sign and symptoms of BawÄsÄ«r DÄmiya (NUMC: F-96) (Bleeding Piles)	At baseline, day 14th, 28th and 42nd day

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessment	At baseline, 14th day and at the end of treatment

Locations (2): Clinical Research Unit, Meerut
🇮🇳
Meerut, UTTAR PRADESH, India
Regional Research Institute of Unani Medicine (RRIUM), Patna
🇮🇳
Patna, BIHAR, India
Clinical Research Unit, Meerut
🇮🇳Meerut, UTTAR PRADESH, India
Dr Mohd Tariq Khan
Principal investigator
9012843253
doctormtk@gmail.com