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CTRI Number  CTRI/2024/06/068986 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 10/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A study to evaluate the effect of hijamah (wet cupping) in the management of hyperlipidaemia.  
Scientific Title of Study   An observational study to compare the efficacy of hijamah bis shurt (wet cupping) and Bed sada (Salix Alba) in the management of tassamum fid dam (hyperlipidaemia)  
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 Tabasum Fatima 
Designation  Research Associate 
Affiliation  Islamic University of Science and Technology 
Address  Islamic University of Science and Technology, Awantipora.Department: Centre for AYUSH Sciences, Ayush health and wellness centre, OPD no:1

Pulwama
JAMMU & KASHMIR
192122
India 
Phone  9419421375  
Fax    
Email  tabasumfatima281@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tabasum Fatima 
Designation  Research Associate 
Affiliation  Islamic University of Science and Technology 
Address  Islamic University of Science and Technology, Awantipora. Department: Centre for AYUSH Sciences, Ayush health and wellness centre, OPD no:1

Pulwama
JAMMU & KASHMIR
192122
India 
Phone  9419421375  
Fax    
Email  tabasumfatima281@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tabasum Fatima 
Designation  Research Associate 
Affiliation  Islamic University of Science and Technology 
Address  Islamic University of Science and Technology, Awantipora.Department: Centre for AYUSH Sciences, Ayush health and wellness centre, OPD no:1

Pulwama
JAMMU & KASHMIR
192122
India 
Phone  9419421375  
Fax    
Email  tabasumfatima281@gmail.com  
 
Source of Monetary or Material Support  
Islamic University of Science and Technology, Awantipora, Pulwama, Jammu & kashmir, India, 192122. 
 
Primary Sponsor  
Name  Islamic University of Science and technology 
Address  Islamic University of Science and Technology, Awantipora, Pulwama, Jammu & Kashmir, Pin-192122, 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 
Dr Tabasum Fatima  AYUSH Wellness centre.  Islamic University of Science and Technology.Department: Centre for AYUSH Sciences, Ayush health and wellness centre, OPD no:1
Pulwama
JAMMU & KASHMIR 
9419421375

tabasumfatima281@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Islamic University of Science and technology  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E789||Disorder of lipoprotein metabolism, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bark of Salix Alba.  Boil 7 grams of dried and powdered bark of Salix Alba in 35ml of water and strain, then taken in the morning after breakfast. This treatment will be taken for a period of two months. 
Intervention  Hijamah bis shurt  The area will be selected and cleaned thoroughly with betadine, then two cups will be taken and suction will be applied with the help of a suction machine for five minutes after which cuts will be made with sterile 11 no surgical blade and the cups are applied again and suction applied again and blood is taken out till another five minutes, then the cups will be removed and will be disposed properly, the wound will be cleaned again and surgical dressing will be applied. This procedure will be done every 15 days for two months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients of either sex will be selected for the study.
2.Between 18 to 60 years of age.
3.Patients with deranged blood lipid profile levels
 
 
ExclusionCriteria 
Details  1.Patients below 18 and above 60 years of age.
2.Pregnant and Lactating mothers.
3.Patients who fail to give consent.
4.Patients with history of severe illness, Cardiovascular diseases, Renal, Liver diseases.
5.Anaemic patients, Patients on blood thinners, Patients with history of bleeding disorders.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Lipid Profile (Triglycerides and LDL)  Baseline and after 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Breathlessness
2. Fatigue
3. Palpitations.
 
Baseline, 2 weeks, 4 weeks, 6 weeks & 8 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   N/A 
Date of First Enrollment (India)   15/07/2024 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [tabasumfatim281@gmail.com].

  6. For how long will this data be available start date provided 10-07-2026 and end date provided 01-02-2050?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Hyperlipidaemia/Dyslipidaemia (Fart e Tassamum fid dam) is a major health problem as it plays an important role in the development of coronary artery disease (CAD) and is responsible for more than four million deaths annually and also accountable for developing IHD worldwide. In Asia, the prevalence of coronary heart disease (CHD) is approximately four times higher as compared to the general population in the USA. If it is not monitored properly or left untreated, it affects overall health and could lead to catastrophic consequences like atherosclerosis, stroke, and ischemic heart disease (IHD). Studies have proved well well-established association between dyslipidemia and the development of cardiovascular diseases. In the Unani system, it is described elaborately about the ill effects of management, if fat is pathologically increased in blood. When these oily substances of blood reach different organs of the body, they start to deposit there in the form of fat (Shahm) due to BaridMizaj (Cold temperament) of those organs.Siman-eMufrit (obesity)has also been discussed extensively and managed in the Unani system of medicine (USM) for centuries. The possible consequences of obesity are Khafqan (palpitation),Salabat-e-Nabz (Atherosclerosis), Sakta (Stroke), Zeeq-un-Nafas(breathlessness), Coma, and sudden death are very much similar to the signs, symptoms and complications of dyslipidemia defined in conventional medicine. Hence, Siman-e-Mufrit is a disease in which there is a deposition of BaridRatabMad’da(Shahm/Lipid) and it falls under the category of Amraz-e-Balghamiya.In Unani classical literature Barg-e-Bed Sada has some actions, like Muqawwi-e-Dimag (Brain Tonic), Muqawwi-e-Qalb (Cardiac Tonic), Zof-e-Meda (Cardiac Asthenia), Mudir-e-Baul (Diuretic), Qabiz (Astringent). So, it is used to cure many diseases such as Tape-Haar (Acute Fever), Ramad (Acute Conjectivitis), Sara (Epilepsy), Yarqaan (Jaundic), Warm-e-Tihal (Hepatomegelly), Khafqaan (Palpitation), Jadri (Chickenpox), Ikhtinaq-i-Reham (Hysteria), Waja-ul-Mafasil (Arthritis), Niqras. Hijamah is also used for the treatment of Hyperlipidaemia. The present study was designed to compare the efficacy of regimenal therapy and pharmacotherapy and determine which was more efficacious

Study design: Open, comparative study.

 

Sample size: 30 patients; 15 in each group.

 

Intervention. Hijamah bis Shurt

 

Number of Cups: 2 cups on interscapular area.

 

Test Drug: Salix Alba

 

Part used:Bark

 

Dosage: 7 grams

 

Method of Prepration:Boil 7 grams of dried and powdered bark of Salix Alba in 35ml of water and strain, then taken in the morning after breakfast.

Duration and Procedure of Intervention:

The area will be selected and cleaned thoroughly with betadine, then two cups will be taken and suction will be applied with the help of a suction machine for five minutes after which cuts will be made with sterile 11 no surgical blade and the cups are applied again and suction applied again and blood is taken out till another five minutes, then the cups will be removed and will be disposed properly, the wound will be cleaned again and surgical dressing will be applied. This procedure will be done every 15 days for two months.

Duration of Study: 2 years

Procedure of study:

Enrolled cases of dyslipidaemia will be randomly allocated into two groups of 15 each, after obtaining a written informed consent. Group A will be allocated forHijamahbisShurt(Wet cupping)  and Group B will be treated with Salix Alba.

The pre and post treatment subjective and objective findings (effects) will be compared in both groups, and its significance will be evaluated through a suitable statistical test.

 
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