| CTRI Number |
CTRI/2017/08/009407 [Registered on: 18/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
28/06/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the safety and efficacy of Unani medicines( Karafas and Duqu) in the management of Urolithiasis. |
|
Scientific Title of Study
|
To Evaluate the efficacy of Unani medicines Tukhm-e-Karafs(Apium graveolans Linn)and Tukhm-e-Duqu (Peucedanum grande C.B.Clarke) in the management of Sangi Gurda wa Masana(Urolithiasis) in a clinical study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohd Rafi Thoker |
| Designation |
PG scholar |
| Affiliation |
Govt. Nizamia Tibbi College Charminar Hyderabad |
| Address |
Department of Ilmul Advia(Pharmacology) Govt. Nizamia Tibbi College Charminar Hyderabad Telangana State
Hyderabad
ANDHRA PRADESH
200005
India |
| Phone |
9622553118 |
| Fax |
|
| Email |
drrafithoker73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Mir Yousf Ali |
| Designation |
Professor And Head of the Department |
| Affiliation |
Govt. Nizamia Tibbi College Charminar Hyderabad |
| Address |
Department of Ilmul Advia(Pharmacology) Govt. Nizamia Tibbi College Charminar Hyderabad Telangana State
Hyderabad
ANDHRA PRADESH
200005
India |
| Phone |
9848089126 |
| Fax |
|
| Email |
drmeer07@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohd Rafi Thoker |
| Designation |
PG scholar |
| Affiliation |
Govt. Nizamia Tibbi College Charminar Hyderabad |
| Address |
Department of Ilmul Advia(Pharmacology) Govt. Nizamia Tibbi College Charminar Hyderabad Telangana State
Hyderabad
ANDHRA PRADESH
200005
India |
| Phone |
9622553118 |
| Fax |
|
| Email |
drrafithoker73@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support
1.Govt. Nizamia Tibbi College and General Hospital Hyderabad.
2.Central Resarch Institute in Unani Medicine (CRIUM) Hyderabad |
|
|
Primary Sponsor
|
| Name |
Govt Nizamia Tibbi College Hyderabad |
| Address |
Charminar Hyderabad Telanga State |
| Type of Sponsor |
Other [Govt. Nizamia Tibbi College Charminar Hyderabad] |
|
|
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 Mohd Rafi Thoker |
Govt. Nizamia Tibbi College |
Department of Ilmul Advia(Pharmacology),Room No.1, First Floor
Hyderabad
ANDHRA PRADESH |
9622553118
040-24522048
drrafithoker73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Govt. Nizamia Tibbi College Hyderabad |
Approved |
| Institutional Ethics Committee Govt. Nizamia Tibbi College Hyderabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Hasal al Kulya wa Masana(Urolithiasis), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NIl |
| Intervention |
Unani medicine Tukhmi Karafas and Tukhmi Duqu |
4gm in two divided doses for 06 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with established Sangi Gurda wa Masana (Urolithiasis) proved by radiological or sonological investigations.
2.Hematologic and Biochemical parameters within normal limits.
3.Patients with normal liver and kidney function.
3.Patients willing to continue whole period of trial with their written consent. |
|
| ExclusionCriteria |
| Details |
1.Patients with impaired liver and kidney function.
2.Patients with urolithiasis causing obstruction needing emergency management.
3.Patients already on some medication for urolithiasis.
4.Pregnant and lactating women.
5.Patients unwilling to provide informed consent or abide by the requirements of the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Symptomatic relief from clinical symptoms of urolithiasis |
06 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in size of stone or expulsion of stone by viewing ultrasonological impression. |
06 weeks |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2016 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is open, non randomized and non comparative clinical trial to asses the safety and efficacy of unani medicine Tukmi Karafs(Apium graveolans) and Tukmi Duqu(Peucedanum grande) in patients with HasÄh al-Kulya wa Masana(Urolithiasis).The patients were selected from OPD of Govt. Nizamia General Hospital Charminar. After screening, the 30 patients of established Urolithiasis were enrolled according to inclusion and exclusion criteria. The patients will be assessed clinically at every two weeks for subjective assessment of general well being and physical examination . The total duration of treatment will be six weeks. Laboratory investigations(Routine and specific) will be conducted at the initiation and on the completion of the protocol therapy. The drugs selected for trial were identified, authenticated and standardized at Central Research Institute in Unani Medicine(CRIUM) Hyderabad.The drugs will be given to the patients in the powder form in the dosage of 4gm per day in two divided doses. |