| 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.
|
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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. |
|
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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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
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|
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.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
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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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [tabasumfatim281@gmail.com].
- 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.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
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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. |