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CTRI Number  CTRI/2024/11/076776 [Registered on: 13/11/2024] Trial Registered Prospectively
Last Modified On: 07/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   An interventional study on effects of sitz bath and marham e maazu in participants having early stage of hemorrhoids 
Scientific Title of Study   A study on Efficacy of Aabzan followed by local application of Marham e Maazu in early stages of Bawasir [Hemorrhoids] 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hafsa 
Designation  PG Scholar 
Affiliation  Govt Nizamia Tibbi College and General Hospital 
Address  Department of preventive and social medicine OPD Division, Room number 102, Govt Nizamia Tibbi College and General Hospital Charminar Hyderabad

Hyderabad
TELANGANA
500002
India 
Phone  7075258282  
Fax    
Email  hafsanayeem36@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohammad Maqbool Hussain 
Designation  HOD Professor  
Affiliation  Govt Nizamia Tibbi College and General Hospital Charminar Hyderabad 
Address  Department of preventive and social medicine, OPD Division, Room number 102,Govt Nizamia Tibbi College and General Hospital Charminar Hyderabad

Hyderabad
TELANGANA
500002
India 
Phone  9948679786  
Fax    
Email  maqboolahmar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Hafsa 
Designation  PG Scholar 
Affiliation  Govt Nizamia Tibbi College and General Hospital Charminar Hyderabad 
Address  Department of preventive and social medicine, OPD Division, Room number 102,Govt Nizamia Tibbi College and General Hospital Charminar Hyderabad

Hyderabad
TELANGANA
500002
India 
Phone  7075258282  
Fax    
Email  hafsanayeem36@gmail.com  
 
Source of Monetary or Material Support  
Govt Nizamia Tibbi College and General Hospital Charminar Hyderabad 500002 
 
Primary Sponsor  
Name  Govt Nizamia Tibbi College  
Address  Govt Nizamia Tibbi College and General Hospital Charminar Hyderabad 500002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hafsa  Govt Nizamia Tibbi College and General Hospital   Department of preventive and social medicine, OPD Division ,Room no. 102
Hyderabad
TELANGANA 
07075258282

hafsanayeem36@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Govt Nizamia Tibbi College Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K641||Second degree hemorrhoids,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Conservative treatment using sitz bath and ointment for hemorrhoids  Subjects having grade 1 and 2 hemorrhoids will be given Alum [shab e yamani] to be used in sitz bath and Gall ointment [marham e maazu] for local application, twice daily. Treatment will be given for 2 weeks and follow up will be done on 7th, 14th day and post treatment follow up will be done on 21st day wherein subjects will be enquired for changes in their symptoms and will be clinically assessed.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Female patients having uncomplicated hemorrhoids, of age 18-45 years.
External, interno external and internal hemorrhoids [grade 1 and 2]
 
 
ExclusionCriteria 
Details  Patients who are not giving informed consent.
Pateints below 18 or above 45. Male patients.
3rd and 4th degree hemorrhoids, Pregnancy , DM or any other rectal disease .

 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Reduction in rectal bleeding, rectal pain, rectal itching, mass per rectum , discomfort during defecation.  On Day 7,14 and 21 
 
Secondary Outcome  
Outcome  TimePoints 
TO resolve hemorrhoids and improve the well-being and quality of life of patients having hemorrhoids.  Day 21 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Title of topic

A study on “ EFFICACY OF SITZ BATH FOLLOWED BY

APPLICATION OF MARHAM E MAAZU IN EARLY STAGES OF

HEMORRHOIDS” in patients attending OPD of tahaffuzi wa samaji tib at Govt Nizamia  General Hospital, Charminar ,Hyderabad


Brief resume of intended work

 

NEED OF THE STUDY

 

Hemorrhoids also called piles are dilated plexus of superior hemorrhoidal veins within the anal canal in subepithelial region. [1][2]

It is one of the most common proctologic conditions in adults.[27]

Although, hemorrhoids are a prevalent anorectal disease with greater socio-economic impact on quality of life of the patients, the epidemiological data is very limited as many patients do not reveal it or avoid seeking medical advice. According to National Institute of Health, the prevalence rate of hemorrhoid is 4.4 %, and approximately 50–86% individuals suffer from hemorrhoids globally. In India, hemorrhoid is reported to be 30–40% in the target population [31] almost 40 million people are reported to have hemorrhoids and one million new cases are reported annually at rate of 47 per 1000 people.[33]

It is not selective for any age or sex[1][5].

According to various unani and modern literature, sitz bath and local application of ointment having antihemorrhoidal properties are beneficial as a means of conservative treatment. [1][2][4][5][9][14][17] Shab e Yamani and maazu having strong astringent, hemostatic, antiseptic and wound healing properties are recommended for this purpose. [8][14][16][17][22][23][24][28]

This study aims at evaluating the efficacy of Marham maazu and sitz bath containing Shab e Yamani, for their anti-hemorrhoidal properties, and to prevent further complication of hemorrhoids.

In the view of above facts, I would like to conduct a study on evaluating – “EFFICACY OF SITZ BATH  FOLLOWED BY APPLICATION OF MARHAM E MAAZU IN EARLY STAGES OF HEMORRHOIDS” in patients attending OPD of tahaffuzi wa samaji tib at Govt Nizamia General Hospital, Charminar, Hyderabad.


MANAGEMENT:

Allopathy management includes conservative /non-operational and operational measures.[1] Conservative methods include increasing fiber supplements, fluid intake, bulk purgatives like ispagol, avoid straining, bowel regulations, sitz bath, applying topical ointments to reduce pain edema and itching.

Antibiotics laxatives and anti-inflammatory drugs are also beneficial.[1][2][4]

Para surgical procedures like sclerotherapy, banding, cryotherapy, etc. are used.[1]

Operative procedure like hemorrhoidectomy is recommended for grade 3 and 4 hemorrhoids.[2]

 

Unani principal of treatment includes pharmacotherapy, Regimental therapy, diet therapy and surgery. [33] Usool e ilaj -

â–ª        Real cause should be identified and eliminated [8]

â–ª         Tanqiya e mawad (evacuation), talayyin (laxative), taskeen e dard (analgesic), habis ud dam(hemostatic), indemal and tahleel e warm (healing and resolution of swelling. [19]

Pharmacotherapy- Various drugs having antihemorrhoidal properties like muqil,raswat, habb e bawaseer etc. Local application of medicine.[19]

Regimental therapy – Fasd, leech therapy, hijama, aabzan.[17][20]

Diet therapy- avoid food that produces melancholic blood, avoids hot spicy food and meat. Diet should contain soft and easily digestible food.[25]

Surgery- unani physicians described 3 types of surgery i.e., Khazam, Shad, Qata.[10]

 

DIFFERNTIAL DIAGNOSIS:[1]

§  Fissure in Ano

§  Fistula in Ano

§  Rectal prolapse

§  Perianal warts

COMPLICATIONS:[2][3]

§  Chronic anemia

§  Thrombosis and Strangulation

§  Fibrosis and Ulceration

§  Gangrene and Portal pyemia


 

 

ABZAN [SITZ BATH]

Among the various treatments, abzan is a simple, economic, safe , noninvasive and effective external regimen for various diseases. [34]

It is type of bath in which the lower part of the body especially buttocks and hips are immersed into plain or medicated water. [21][35]

Various unani literature suggest using astringent drugs like shab e yamani [14] dissolved in water (aab e qaabiza) for sitz bath in hemorrhoids.[9][14][17][25][26]

Shab e yamani ( aluminium hydroxide) is a mineral drug having mizaj garam and khushk. Its main properties are Qabiz, Habis ud dam, Musakkin, Mujaffif

Maazu (quercus infectoria) is  sard and khushk in mizaj . Its properties are Qabiz, Mujaffif,Habis ud dam and Dafe taffun. It  contains tannic acid and gallic acid, which makes it a potent astringent, hemostatic and antimicrobial agent, that benefits patients with hemorrhoids.[22][23]

 

6.3

AIMS AND OBJECTIVES OF THE STUDY:

§  This study aims at evaluating the efficacy of sitz bath and application of Marham e maazu in early stages of hemorrhoids.

§  The objective of this study is to create awareness regarding prevention and management of hemorrhoids and improving the well-being and quality of life of patients having hemorrhoids.

7

MATERIALS AND METHODS

 

7.1

SOURCE OF DATA –

Patients attending OPD of tahaffuzi wa samaji tib at government Nizamia general hospital, Charminar Hyderabad.

 

INCLUSION CRITERIA:

Female patients having uncomplicated hemorrhoids, of age 18-45 years.

External, interno external and  internal hemorrhoids [grade 1 and 2]

 

EXCLUSION CRITERIA:

Patients who are not giving informed consent.

Pateints below 18 or above 45. Male patients.

  3rd and 4th degree hemorrhoids, Pregnancy , DM or any other rectal disease .

 

PARAMETERS FOR STUDY :

§  SUBJECTIVE PARAMETRS-

Patients complaining of rectal bleeding, rectal pain, rectal itching, mass per rectum , discomfort during defecation.

§  OBJECTIVE PARAMETERS-

The diagnosis is based on history taking and clinical examination.

 

STUDY DESIGN: An experimental - Single arm clinical study

 

SAMPLE SIZE: minimum 30

 

DURATION OF STUDY: 9 months


 

PROCEDURE OF STUDY:

This study will be conducted on 30 subjects meeting the inclusion criteria.

The subjects will be screened for pain intensity, defecation discomfort, anal itching, per rectal bleeding, change in size of external hemorrhoids using suitable scales. Subjects will be given shab e yamani to be used in sitz bath and marham e maazu for local application, twice daily.

Treatment will be given for 2 weeks and follow up will be done on 7th, 14th day and post treatment follow up will be done on 21st day wherein subjects will be enquired for changes in their symptoms and will be clinically assessed.

The purpose of not using a control group or placebo is that the symptoms of hemorrhoids may further get complicated.

 

METHOD OF PREPATATION:

   

    MARHAM E MAAZU : 50 g of finely powdered maazu is to be mixed with 500g of Mom-Safed. It is then ground in mortar and pestle to render into an ointment and stored in glass container. [36]

    

    SUFOOF E SHAB E YAMANI :   Shab e yamani is roasted in iron pan at moderate heat. After it melts and dries down it is ground in mortar and pestle to achieve fine powder.[28]

 

For the purpose of sitz bath , 20g of Shab e yamani is to be dissolved into 2L of lukewarm water in a tub and sit into it for 10-15 minutes twice daily, followed by local application of Marham e Maazu in sufficient quantity .

 

EVALUATION: Data will be analyzed statistically.


 
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