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CTRI Number  CTRI/2023/04/051674 [Registered on: 17/04/2023] Trial Registered Prospectively
Last Modified On: 09/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical Comparative efficacy and safety of Unani Drugs 
Scientific Title of Study   A comparative study of Sharbat toot siyah with laooq sapistan in the management of waram-i-halaq Muzmin (Chronic Pharyngitis)” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Md Mokarram 
Designation  PG scholar 
Affiliation  State Unani Medical College, Himmatganj, Prayagraj-211016 
Address  Department of Amraze Ain Uzn Anf Halaq wa Asnan, State Unani Medical College, himmatganj Prayagraj 211016 India Allahabad UTTAR PRADESH 211016 India

Allahabad
UTTAR PRADESH
211016
India 
Phone    
Fax    
Email  mdmokarram178@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Mohd Asif Hussain Usmani 
Designation  Professor and Head of the department  
Affiliation  State Unani medical College Prayagraj 
Address  Department of Amraze Ain Uzn Anf Halaq wa Asnan, State Unani Medical College, himmatganj Prayagraj 211016 India Allahabad UTTAR PRADESH 211016 India

Allahabad
UTTAR PRADESH
211016
India 
Phone  7905831926  
Fax    
Email  asifhussainusmani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Usamah Ahmad 
Designation  Associate Professor 
Affiliation  State Unani Medical College Prayagraj 
Address  Department of Amraze Ain Uzn Anf Halaq wa Asnan, State Unani Medical College, himmatganj Prayagraj 211016 India Allahabad UTTAR PRADESH 211016 India

Allahabad
UTTAR PRADESH
211016
India 
Phone  9415639877  
Fax    
Email  Arogyaherbal@gmail.com  
 
Source of Monetary or Material Support  
State Unani Medical College Prayagraj, Ministry of AYUSH, U.P govt. 
 
Primary Sponsor  
Name  State Unani Medical College, himmatganj Prayagraj 
Address  Department of Amraze Ain Uzn Anf Halaq wa Asnan, State Unani Medical College, himmatganj Prayagraj 211016 India Allahabad UTTAR PRADESH 211016 India 
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 
Md Mokarram  OPD/IPD of Ain, Uzn, Anf, Halaq wa Asnan n State Unani Medical  State Unani Medical College & HAHRDM Hospital Prayagraj 211016 Allahabad UTTAR PRADESH
Allahabad
UTTAR PRADESH 		 9997663773

mdmokarram178@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J312||Chronic pharyngitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Laooq Sapistan(Oral)  Laooq Sapistan (7 gm) with luke water will be given of twice a day for the same duration 
Intervention  Sharbat Toot Siyah (Oral)  Sharbate Toot Siyah (25 ml) will be given orally twice a day for 6 week 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients of either sex in the age group of 18-60 years
2 Patient with clinically diagnosed with Waram-i-halaq (Chronic Pharyngitis)
3 Patient with raised Absolute eosinophil count and Complete blood count. 
 
ExclusionCriteria 
Details  Age below 18 and above 60years.
1 Pregnancy and lactation.
2 Those have history of systematic and metabolic disease.
3 Those diagnosed with any other disease of the nose and throat 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Efficacy will be assessed clinically by improvement in clinical features and following parameter.
1. Improvement of subjective parameters.
2. Reduction in Visual Analogue Scale (VAS)
3. Reduction in Absolute Eosinophil count and CBC
 		 0, 7, 14, 21, 28,
35, 42 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Clinical Sign and Symptoms  0 and 6th week 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 3 
Date of First Enrollment (India)   25/04/2023 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Pharyngitis is defined as mucosal inflammation of the oropharynx, hypopharynx, adenoid and tonsils. It is a type of inflammation caused by an upper respiratory tract infection. It may be classified as acute or chronic. Acute pharyngitis may be catarrhal, purulent, or ulcerative, depending on the causative agent and the immune capacity of the affected individual. Chronic pharyngitis may be catarrhal, hypertrophic or atrophic. Chronic inflammatory condition of the pharynx pathologically, characterized by hypertrophy of mucosa, seromucinous glands, subepithelial lymphoid follicles, and even the muscular coat of the pharynx . Virus is the most common cause of pharyngitis. About 25% children and 10% of adults are affected by Streptococcal pharyngitis. Uncommon cause are some other bacteria (gonorrhoea), fungus, irritantssmoke, allergens, and gastroesophageal reflux disease. Chronic pharyngitis has many potential underlying causes, and if a sore throat does not clear up even after a course of antibiotics, it is best to seek further medical advice. It often indicates the presence of an underlying problem, and 3 3 6.2 treatment to relieve it includes treating the underlying cause. To relieve the sore throat itself, people with chronic pharyngitis can gargle with warm saline solutions, stay wellhydrated, avoid smoking and manage pain with over-the-counter medication such as acetaminophen/paracetamol6 . But acetaminophene have various side effects like hypersensitivity reactions, nephrotoxicity, anemia and may cause severe adverse effects include anaphylactic reaction . Fortunately our Unani system of medicine provides very effective treatment for Pharyngitis. It is mentioned in classical Unani literature as Waram-i-Halaq. It is described as the inflammation of Ghisha-e-mukhati (mucous membrane) of Halaq (Pharynx)8 . There are many single and compound drugs for the management of pharyngitis which are being used for a longer duration without any known side effects for example, Khyar Shambhar (Cassia fistula Linn), Banafsha (Viola odorata Linn), Milk of Fig, Tukhm e Hulba (Trigonella foenum)etc9 . So there is need to develop alternative herbal medicines to cure the Waram-i-Halaq. By keeping this background in the mind this study is being drawn after very comprehensive and thorough review of classical Unani literature regarding sign & symptoms, clinical examination, medical management. 
keeping the above facts in view, it has been planned to conduct a clinical trial entitled “A comparative study of Sharbat Toot Siyah with Laooq Sapistan in the management of Waram-i-Halaq Muzmin (Chronic Pharyngitis)”-A randomized Trial
 
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