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CTRI Number  CTRI/2025/01/079065 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluate the effectiveness of two Unani medicines in the treatment of piles  
Scientific Title of Study   Comparative Evaluation of Efficacy Of habb e Sandroos and habb e Rasuat In Internal 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  NAVEEN KUMAR M R  
Designation  PG SCHOLAR 
Affiliation  National Institute of Unani Medicine  
Address  Department Of Ilmul Jarahat National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru 560091 Karnataka India
Bengaluru Karnataka 560091 India
Bangalore
KARNATAKA
560091
India 
Phone  9606284543  
Fax    
Email  naveenrockroaring@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mehjabeen Fatimah  
Designation  Assistant Professor  
Affiliation  National Institute of Unani Medicine  
Address  Department Of Ilmul Jarahat National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru 560091 Karnataka India
Bengaluru Karnataka 560091 India
Bangalore
KARNATAKA
560091
India 
Phone  8057438462  
Fax    
Email  fatimahmehjabeen@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mehjabeen Fatimah  
Designation  Assistant Professor  
Affiliation  National Institute of Unani Medicine  
Address  Department Of Ilmul Jarahat National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru 560091 Karnataka India
Bengaluru Karnataka 560091 India
Bangalore
KARNATAKA
560091
India 
Phone  8057438462  
Fax    
Email  fatimahmehjabeen@gmail.com  
 
Source of Monetary or Material Support  
National institute of Unani medicine kottigepalya Magadi main road Bengaluru 560091 Karnataka India Karnataka India  
 
Primary Sponsor  
Name  National Institute Of Unani Medicine  
Address  Department Of Ilmul Jarahat National Institute Of Unani Medicine Kottigepalya Magadi Main road Bangalore 560091 Karnataka India Bengaluru 560091 Karnataka India  
Type of Sponsor  Research institution and hospital 
 
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 Naveen Kumar   National Institute Of Unani Medicine   Patient Attending the OPD and IPD, Department of Ilmul Jarahat, National Institute of Unani Medicine Kottigepalya Magadi Main road Bengaluru 560091 Karnataka India
Bangalore
KARNATAKA 
9606284543

naveenrockroaring@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of decision of the Institutional Ethics Committee (IEC) for Biomedical Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K648||Other hemorrhoids,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  HABB-e-RASUAT orally 2 pills each weighing 500mg thrice a day for 28 days   HABB-e-RASUAT will be prepared by following ingredients 1) Rasuat(Berberis vulgaris) 2) Kateera(Cochispernum religiosum) 3) Mazu(Cuercus infectori) 4)Sang-e-Jarahat(Soap stone) 5)Geru(Red chalk ) 
Intervention  HABB-e-SANDROOS orally 2 pills each weighing 500mg thrice a day for 28 days   HABB-e-SANDROOS will be prepared by following ingredients 1) Sandroos(Trachylobium hornemannianum 2) Shitraj Hindi(Plumbago zeylanica) 3) Post-e-Beza Murgh Sokhta(Egg shell) 4) Tukhm Gandana(Alliumam ampeloprasum) 5) Khabsul Hadeed Sokhta(ferric oxide) 6) Muqil( Commiphora Muqil) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Diagnosed case of internal haemorrhoids grade 1 and 2
2) Patients who have agreed to sign the informed consent form and follow up the protocol  
 
ExclusionCriteria 
Details  1) External Pile mass
2) Severe systemic illness including IBD, Liver cirrhosis Portal Hypertension
3) Pregnant and lactating women
4) Haemorrhoids associated with other Anorectal diseases like rectal polyp, Fissure in Another,Fistula in Another,Carcinoma of Rectum and Anal , STDs  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in mass and bleeding per Rectum   28 days  
 
Secondary Outcome  
Outcome  TimePoints 
Per Rectal Mucus discharge
Perianal Itching
Defecation discomfort  
28 days  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 2 
Date of First Enrollment (India)   01/03/2025 
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="1"
Months="6"
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  
As per Unani literature haemorrhoid i s known a s "Bawaseer". Bawaseer is
pleural o f basoor which means warts o r polyp like swelling. I t i s a n excessive
growth at the mouth of vessels present in anus which forms due t o ghaleez khilt
-e-sauda." According to Majoosi, Bawaseer is an excessive growth at mouth of
vessels present i n anus. 12 Whereas Ibn Hubal Baghdadi described that the
formation o f Bawaseer indicates t h a t t h e morbid viscid humour (ghaleez
akhalat) is present in the body. 3
Classification: Bawäsir h a s been classified in three ways:
1. According to shape 2.According t o site 3.According t o presence or absence
of bleeding
A. According to Shape:
1. Sulüli: polyps in shape of Adasiya (lentil) or Himmasiya (gram) 2. ’Inabiyya:
shape of the polyp resembles with grapes 3 . Tuti: polyp resembles with the
shape of mulberry 4. Naffäkhi: polyps resemble with the shape of small bubble
5. Nakhli: Vessels of the polyps are spread like the branches and roots of date
tree 6. Tini: Shape of the polyps is flat and round similar to that of Injir (fig) 7.
Tamri: Shape of the polyps is similar to shape of date i.e. long and oval
B.According t o Site: These are of three types: 1. Bawäsir-e-ghaira (internal
piles): haemorrhoidal lesions are deep seated with bleeding and slight pain. 2.
Bawäsir-e-zahira (external piles): haemorrhoidal lesions are located out-side
anal verge and can b e s e e n externally. It i s very painful b u t with scanty
bleeding. It may be Sulüli, ’Inabi or Tüti. 3. Mukhtalit Bawäsir (intro-external
piles): it is mixed o f above two type of Bawäsir marked with severe pain and
profuse rectal bleed!
C.According t o Bleeding: There a r e two types: 1. Bawäsir Damiya o r khunt 
B a w a s t r bleeding piles): there is bleeding and yellowish watery discharge from anus. 2.
Bawäsir Ummiya: there is no bleeding. Only yellowish watery discharge is seen
coming out of anus."
Unani physicians described t h a t t h e khilt-e-sauda i s responsible for this
disease. The pathophysiology o f haemorrhoids i s t h e morbid khilt-e-sauda
which starts t o precipitate in t h e liver a n d pushes towards t h e Ano-rectal
vessels, where it accumulates and leads to formation of haemorrhoids. 
The basic principle of management of haemorrhoids is Izale-sabab (elimination
of cause) that means avoid the food (diet) which forms khilt-e-sauda in body,
Tanqiya-e-ma’dda (evacuation of morbid matter) through venesection, cupping
a n d laxatives. Other m e t h o d s which c a n b e u s e d f o r t h e treatment of
haemorrhoids include correction o f liver, intestine, stomach a n d spleen
because haemorrhoids can never form without Su-e-mizaj of these organs. ",
In Unani system of medicine the drugs used in the treatment of haemorrhoids
should have following properties like Habis-ud-dam (Haemostatic), Mullayin
(Laxative), Muhallille Warm (Anti Inflamatory), Mujaffif (Desiccative), Mudammil
(Healing property), and Musakkin-e-alam (Analgesic)  
Based on above principle mentioned intervention is being evaluated for its efficacy in the management of internal haemorrhoids 
 
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