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CTRI Number  CTRI/2024/10/075828 [Registered on: 24/10/2024] Trial Registered Prospectively
Last Modified On: 23/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effect of Unani drugs in patient with worm infestation 
Scientific Title of Study   An open labelled randomized controlled clinical trial to evaluate safety and efficacy of qurse deedane jadeed in case of deedane tiwal [ascaris lumbricoides] 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrGulafshan Begum 
Designation  PG Scholar 
Affiliation  Govt. Nizamia Tibbi College and General Hospital, Charminar, Hyderabad. 
Address  OP No. 207, Room No. 122, PG Dept. Of Moalijat Govt. Nizamia Tibbi College and General Hospital, Charminar, Hyderabad.

Hyderabad
TELANGANA
500002
India 
Phone  9398107721  
Fax  00  
Email  gulafshan277@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrN Narsimha 
Designation  Professor 
Affiliation  Govt. Nizamia Tibbi College and General Hospital, Charminar, Hyderabad. 
Address  Room No. 207, PG Dept. Of Moalijat Govt. Nizamia Tibbi College and General Hospital, Charminar, Hyderabad.

Hyderabad
TELANGANA
500002
India 
Phone  9866985269  
Fax  00  
Email  dr.n.narasimha@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrN Narsimha 
Designation  Professor 
Affiliation  Govt. Nizamia Tibbi College and General Hospital, Charminar, Hyderabad. 
Address  OP No. 207, Room No. 122, PG Dept. Of Moalijat Govt. Nizamia Tibbi College and General Hospital, Charminar, Hyderabad.

Hyderabad
TELANGANA
500002
India 
Phone  9866985269  
Fax  00  
Email  dr.n.narasimha@gmail.com  
 
Source of Monetary or Material Support  
Govt. Nizamia Tibbi College and General Hospital, Charminar, Hyderabad, Telangana, India, 500002. 
 
Primary Sponsor  
Name  Govt Nizamia Tibbi College and General Hospital PG Dept of Moalijat 
Address  Govt. Nizamia Tibbi College and General Hospital, Charminar, Hyderabad, Telangana, India, 500002. 
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 Gulafshan Begum  Govt. Nizamia Tibbi College and General Hospital  OP No. 207, PG Dept. Of Moalijat Govt. Nizamia Tibbi College and General Hospital, Charminar, Hyderabad.
Hyderabad
TELANGANA 		 9398107721

gulafshan277@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Govt. of Telangana, Govt. Nizamia Tibbi College Hyderabad, 500002, Telangana State, Affiliated to Kaloji Narayana Rao University of Health science, Warangal, Telangana State Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B770||Ascariasis with intestinal complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Anti Helmenthic Drug - Albendazole  Dossage details: - 400 mg for adults - 200 mg for children 
Intervention  UNANI DRUG - Qurse-Deedane Jadeed  Twenty patients are treated with the Unani formulation Qurse-Deedane Jadeed for 14 days to assess efficacy. Dossage details: (1 Tab - 775 mg), 2 - Tabs for Adults, 1 - Tabs for children. Total duration 6 months. 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. History of Passing an Adult Worm.
2. Patient Complaining of Abdominal Pain, Fever, Nausea/Vomiting Increase and decrease in Appetite.
3. Allergic Manifestation, Itching, Urticaria.
4. Both Gender
5. Age between 14 – 45 years 
 
ExclusionCriteria 
Details  1. Severe Abdominal Pain, Severe Growth Retardation, Severe Anemia.
2. Major Medical Illness.
3. Patient with Severe Jaundice.
4. Peritonitis.
5. Evidence of Perforation.
6. Pregnant & Lactating Women 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Cure the worm infestation  Once in a week 
 
Secondary Outcome  
Outcome  TimePoints 
To relieve Abdominal Pain, Growth Retardation and Severe Anemia  Once in a week 
 
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)   05/11/2024 
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="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   Helminthic infections are widespread globally, with the highest incidence and severity seen in developing countries. It’s estimated that around 60% of the world’s population is affected by intestinal worms. In India, pooled data from 127 surveys show a prevalence rate of over 20%. While most infections are mild and asymptomatic, moderate to severe infestations are linked to growth delays, nutritional deficiencies, anemia, and poor academic performance in people from endemic regions. The migration of larval or adult worms also contributes to pulmonary and gastrointestinal health issues. Increasing resistance and side effects from synthetic anthelmintic drugs have sparked growing global interest in using medicinal plants to treat helminthic diseases. 
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