| 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
|
|
|
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
|
|
|
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 - ▪ Real cause should be identified and eliminated [8] ▪ 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.
|
|