| CTRI Number |
CTRI/2024/07/070624 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to evaluate the effectiveness of Safoof-e-Deedan in worm infestation. |
|
Scientific Title of Study
|
A Clinical Study of Deedan-e-Ama (Intestinal Worms) to Assess the Effectiveness of Safoof-e-Deedan |
| 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 Anjum Parveen |
| Designation |
Post Graduate scholar |
| Affiliation |
State Unani Medical College and Hospital |
| Address |
State Unani Medical College and Hospital, Department of Ilmul Atfal,OPD no. 2, Himmatganj Prayagraj U.P
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
7784850606 |
| Fax |
|
| Email |
anjumparveen732@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Md Sohail |
| Designation |
Assistant Professor,HOD incharge Department of Ilmul Atfal |
| Affiliation |
State Unani Medical College and Hospital |
| Address |
State Unani Medical College and Hospital, Department of Ilmul Atfal,OPD no. 2, Himmatganj Prayagraj U.P
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
8279944096 |
| Fax |
|
| Email |
Shlt869@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Md Sohail |
| Designation |
Assistant Professor,HOD incharge Department of Ilmul Atfal |
| Affiliation |
State Unani Medical College and Hospital |
| Address |
State Unani Medical College and Hospital, Department of Ilmul Atfal,OPD no. 2, Himmatganj Prayagraj U.P
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
8279944096 |
| Fax |
|
| Email |
Shlt869@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Unani Medical College and Hospital,Himmatganj,Prayagraj,UP,India 211016 |
|
|
Primary Sponsor
|
| Name |
Dr Anjum Parveen |
| Address |
Department of Ilmul Atfal,OPD no-2,State Unani Medical College and Hospital,Himmatganj,prayagraj,UP,India-211016 |
| Type of Sponsor |
Other [Self] |
|
|
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 Anjum Parveen |
State Unani Medical College and Hospital |
Department of Ilmul Atfal,State Unani Medical College and Hospital, Himmatganj,Prayagraj,UP,India 211016
Allahabad
UTTAR PRADESH |
7784850606
anjumparveen732@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K638||Other specified diseases of intestine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Safoof-e-deedan |
Artemisia absinthium (200gm)
Embelia ribes (200gm)
Ipomea trupthum (200gm)
Rosa damascene (200gm)
Ptychotis ajowan DC (10gm)
Make fine powder and given orally 2-4gm with one spoon of honey at bed time for 10 days |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Patients having history of abdominal pain, decrease appetite, weight loss etc.
Willing to participate in the study and follows instructions. |
|
| ExclusionCriteria |
| Details |
Patients below 5 years and above 14 years.
Patients who fail to follow up.
Known case of any systemic disease i.e.- RHD, Nephrotic Syndrome, Bronchial Asthma, Diabetes,TB, Liver and Blood born disease etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in subjective parameters such as abdominal pain,abdominal distension,decrease appetite,weight loss etc. |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in objective parameters like ova/cyst in Stool and Hb%, DLC and ESR in Blood |
10 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
29/07/2024 |
| Date of Study Completion (India) |
04/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Worm infestation (helminthiasis) is a major health problem in children, particularly in low-income and developing countries.. Helminthiasis caused by 3 groups of worms, nematodes (round worm). cestode (tape worm), and trematodes(flukes).Incidence of round worm infection is about one billion, whip worm infection is about 500 million and hook worn infection is about 900 million per population worldwide. The clinical manifestations associated with worm infestation are abdominal pain, abdominal distention, growth retardation, nutritional deficiencies, pica, sleeplessness, irritability, anaemia when hookworm infestation is present, intestinal obstruction may be found, and some time larva of ascaris migrate to the lungs and cause ascaris pneumonia (Loeffler’s Syndrome), asthma-like manifestation, hepatomegaly, splenomegaly or encephalopathy. In the Unani System of Medicine, the term worm infestation described as Deedan-e-Ama’a. According to classical Unani literature the main cause of formation of Deedan- e-Ama’a (Intestinal worm) is only Balghami Rutoobat (Phlegmatic fluid small intestine. With the help of Hararat-e-Ghariba these Ratubate Balghamiyah become putrefied and lead to the formation of Deedan-e- Ama’a., |