| CTRI Number |
CTRI/2023/12/060627 [Registered on: 21/12/2023] Trial Registered Prospectively |
| Last Modified On: |
20/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effect of unani medicine in piles. |
|
Scientific Title of Study
|
A Randomised single blind,two arms clinical study comparing placebo and unani formulation from authentic pharma copoeia in un complicated Haemorrhoids(Ghair pechide Bawaseer-e-miqad) |
| 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 Dudekula Faheemunnisa |
| Designation |
Pg scholar |
| Affiliation |
Govt.Nizamia Tibbi College and General Hospital,Charminar,Hyderabad. |
| Address |
Govt.Nizamia Tibbi College and General Hospital,Charminar,Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
9494740079 |
| Fax |
|
| Email |
faheemdudekula@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Abdul Khadir Hussaini |
| Designation |
Professor |
| Affiliation |
Govt.Nizamia Tibbi college and General Hospital,Charminar,Hyderabad. |
| Address |
Govt.Nizamia Tibbi College and General Hospital,Charminar,Hyderabad.
Hyderabad
TELANGANA
500002
India |
| Phone |
9704888561 |
| Fax |
|
| Email |
drsakhussaini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dudekula Faheemunnisa |
| Designation |
PG scholar |
| Affiliation |
Govt.Nizamia Tibbi College and General Hospital,Charminar,Hyderabad. |
| Address |
Govt.Nizamia Tibbi College and General Hospital,Charminar,Hyderabad.
Hyderabad
TELANGANA
500002
India |
| Phone |
9494740079 |
| Fax |
|
| Email |
faheemdudekula@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. Nizamia Tibbi College And General Hospital, Charminar Hyderabad Telangana |
|
|
Primary Sponsor
|
| Name |
Government Nizamia Tibbi College and General Hospital |
| Address |
Govt Nizamia Tibbi College and General Hospital,Charminar,Hyderabad. |
| Type of Sponsor |
Research institution 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 |
| Dr Dudekula Faheemunnisa |
Govt Nizamia Tibbi College And General Hospital |
Room No 1, Speciality OPD, PG Department of Moalijat
Hyderabad
TELANGANA |
9494740079
faheemdudekula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethical 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 |
| Comparator Agent |
Placebo - Wheat flour
Lifestyle modification |
500mg BD PO for 35 days |
| Intervention |
Unani Formulation and Sitz bath |
Habb e Bawaseer -1500mg BD PO for 35 days
Sabsoos e Isapghol -5gm BD PO for 35 days
Marham e mazu for local application
Sitz bath in alum for 35 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18-65 years
Both sexes
Patient with symptom prolong constipation
Patient with diagnosis of acute uncomplicated first and second degree Haemorrhoids
Rectal bleeding
Pain on defecation
Prolapse
Mucus discharge
Pruiritis |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Uncontrolled diabetes and hypertension
Complicated case of haemorrhoids like thrombosis, strangulation, gangrene and carcinoma of rectum
Fistula and fissure in ano
Liver disorder
Severe anemia
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in symptoms such as Bleeding per rectum, Prolapse, Mucus dicharge, Pruritis, Pain and discomfort |
Relief in symptoms such as Bleeding per rectum, Prolapse, Mucus dicharge, Pruritis, Pain and discomfort every 7 days for 5 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in associated symptoms such as indigestion and constipation |
Before and after treatment of 35 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 3 |
|
Date of First Enrollment (India)
|
31/12/2023 |
| 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="0"
Months="10"
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
|
This clinical trial is a Randomised, single blind, two arm study which compares placebo with Unani formulation in the patients with Haemorrhoids. The total number of patients will be divided into group A and group B and alloted the placebo along with lifestyle management and unani formulation respectively for 35 days. The primary outcomes will be assessed weekly once for 35 days. |