| CTRI Number |
CTRI/2023/05/053145 [Registered on: 26/05/2023] Trial Registered Prospectively |
| Last Modified On: |
28/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Unani treatment for Haemorrhoids |
|
Scientific Title of Study
|
Comparative evaluation on efficacy of Habb-e-Rasuat vs Habb-e-Muqil in bawaseer ghaira (Internal Haemorrhoids) – An open label Randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
UMER HAMID WANI |
| Designation |
PG SCHOLAR DEPARTMENT OF ILMUL JARAHAT |
| Affiliation |
NATIONAL INSTITUE OF UNANI MEDICINE |
| Address |
NATIONAL INSTITUE OF UNANI MEDICINE,
Kottigepalya, Magadi Main Road, Bangalore
KARNATAKA
560091
India
Bangalore
KARNATAKA
560091
India |
| Phone |
9797985802 |
| Fax |
|
| Email |
hatimjas66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfSaiyad Shah Alam |
| Designation |
HoD DEPARTMENT OF ILMUL JARAHAT |
| Affiliation |
NATIONAL INSTITUE OF UNANI MEDICINE |
| Address |
NATIONAL INSTITUE OF UNANI MEDICINE,
Kottigepalya, Magadi Main Road,
Bangalore
KARNATAKA
560091
India
Bangalore
KARNATAKA
560091
India |
| Phone |
8792683039 |
| Fax |
|
| Email |
shahalam1971@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ProfSaiyad Shah Alam |
| Designation |
HoD DEPARTMENT OF ILMUL JARAHAT |
| Affiliation |
NATIONAL INSTITUE OF UNANI MEDICINE |
| Address |
NATIONAL INSTITUE OF UNANI MEDICINE,
Kottigepalya, Magadi Main Road,
Bangalore
KARNATAKA
560091
India
Bangalore
KARNATAKA
560091
India |
| Phone |
8792683039 |
| Fax |
|
| Email |
shahalam1971@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUE OF UNANI MEDICINE, Kottigepalya, Magadi
Main Road, Bangalore 560091 |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUE OF UNANI MEDICINE |
| Address |
NATIONAL INSTITUE OF UNANI MEDICINE, Kottigepalya, Magadi
Main Road, Bangalore 560091 |
| Type of Sponsor |
Other [Research iinnstitution and hospital] |
|
|
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 |
| Umer Hamid Wani |
NATIONAL INSTITUE OF UNANI MEDICINE |
Department of Ilmul Jarahat,OPD no. 7 , Kottigepalya, Magadi
Main Road, Bangalore KARNATAKA 560091
Bangalore
KARNATAKA |
9797985802
hatimjas66@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
|
|
|
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-MUQIL
orally 3 pills each having weight of 220mg at bed time |
HABB-e-MUQIL will be prepared from the following ingredients in the form of pills :
1.Muqil (Commiphora muqil)
150 g
2.Halela Siyah (Terminalia chebula) 150g
3.Rai (Brassica nigra) 20g
4.Tukhm Gandana
(Alliumam ampeloprasum) 50g
5.Turbud Safaid
(Operculina turpethum Linn.)
100g
6.Post Halela-e-Zard
(Terminalia chebula Retz) 300g |
| Intervention |
HABB-e-RASUAT
orally 2 pills each 180mg twice daily |
HABB-e-RASUAT will be prepared by following ingredients 1.Rasuat(Berberis vulgaris)
2.Gugul (Commiphora mukul)
3.Post Halela-e-Zard
(Terminalia chebula Retz)
each 50g in the form of pills |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed case of internal haemorrhoids grade I and II
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 Ano, Fistula in Ano, Carcinoma of Rectum and Anal canal, STD’s. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
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)
|
01/06/2023 |
| 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
|
after completion of trial,paper will be published in peer reviewed,international journal |
|
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 is known as “Bawaseerâ€. Bawaseer is pleural of basoor which means warts or polyp like swelling. It is an excessive growth at the mouth of vessels present in anus which forms due to ghaleez khilt-e-sauda.11 According to Majoosi, Bawaseer is an excessive growth at mouth of vessels present in anus.12 Whereas Ibn Hubal Baghdadi described that the formation of Bawaseer indicates that the morbid viscid humour (ghaleez akhalat) is present in the body. 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 and laxatives. Other methods which can be used for the treatment of haemorrhoids include correction of liver, intestine, stomach and 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 the above principle above mentioned intervention is being evaluated for its efficacy in the management of internal haemorrhoids. |