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CTRI Number  CTRI/2024/07/071053 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 18/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study On The Effect Of Matbookh-e-Haleela With Local Application Of Zimad In Comparison With Leech Therapy In Stasis Dermatitis. 
Scientific Title of Study   A Comparative Study On The Efficacy Of Matbookh e Haleela With Local Application Of Zimad In Comparison With Taliq al Alaq In Stasis Dermatitis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ghazala Taskeen S 
Designation  PG scholar  
Affiliation  National Institute Of Unani Medicine  
Address  Department Of Amraze Jild Wa Tazeeniyat National Institute Of Unani Medicine Kottigepalya Bangalore 560091 Karnataka India

Bangalore
KARNATAKA
560091
India 
Phone  8072512507  
Fax    
Email  ghazalataskeen05@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof mohd Aleemuddin Quamri 
Designation  HOD Amraze Jild Wa Tazeeniyat & moalajat (i/c) 
Affiliation  National Institute Of Unani Medicine  
Address  Department Of Amraze Jild Wa Tazeeniyat National Institute Of Unani Medicine Kottigepalya Bangalore 560091 Karnataka India

Bangalore
KARNATAKA
560091
India 
Phone  9341072974  
Fax    
Email  drmaquamri@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof mohd Aleemuddin Quamri 
Designation  HOD Amraze Jild Wa Tazeeniyat & moalajat (i/c) 
Affiliation  National Institute Of Unani Medicine  
Address  Department Of Amraze Jild Wa Tazeeniyat National Institute Of Unani Medicine Kottigepalya Bangalore 560091 Karnataka India


KARNATAKA
560091
India 
Phone  9341072974  
Fax    
Email  drmaquamri@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bangalore 560091 Karnataka India 
 
Primary Sponsor  
Name  National Institute Of Unani Medicine 
Address  Department Of Amraze Jild Wa Tazeeniyat National Institute Of Unani Medicine Kottigepalya Bangalore 560091 Karnataka India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 Ghazala Taskeen S  National Institute Of Unani Medicine   Amraz-e-Jild wa Tazeeniyat /OPD 4 and 7/IPD
Bangalore
KARNATAKA 
8072512507

ghazalataskeen05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of Decision of the Institutional Ethics Committee (IEC) for Biomedical Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L308||Other specified dermatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Matbookh e Haleela and leech therapy  TaÊ»lÄ«q al-Ê»Alaq (Leech Therapy) A total of four sittings of leech therapy will be carried out at 7 days intervals. Number of leeches applied will be decided based on the size of the lesion. Two leeches per percent body surface area will be used.and Matbookh-e-Haleela will be given 15 gm orally in the morning before food in every follow up 
Intervention  Matbookh e Haleela And Zimad  Gile-Armani with Sirka and water will be applied as per the requirement on the affected area two times a day for 30 minutes., Matbookh-e-Haleela will be given 15 gm orally in the morning before food till 35th day follow up 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Subjects of all genders between 40 to 70 years of age.
2.Clinically diagnosed cases according to CEAP-C4 criteria.
3.Subjects with lesions Less than 3 percentage of body surface area
4.Patients who will give consent and are able to do follow-up
 
 
ExclusionCriteria 
Details  1.Subjects below 40 and above 70 years
2.Pregnant and lactating women’s
3.K/c/o thrombophlebitis, venous ulceration, other dermatological disorders
4.H/O psychiatric and cardiovascular disorders
5.Uncontrolled Diabetes mellitus
6. Subjects with H/O bleeding tendency.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes In TSS  0th Day,7th Day,14th Day, 21st Day,28th Day 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in VAS, SF36 quality of life index, and changes in Photographs  0th Day,7th Day,14th Day, 21st Day,28th Day 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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)   30/07/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Need of the study:

    Stasis Dermatitis, a term synonymous with venous eczema and gravitational eczema, is a common condition secondary to venous hypertension.1 Stasis Dermatitis, characterized by erythema, scaling, pruritis, erosion, oozing, crusting, and occasional vesicles may occur. It typically occurs in the medial supra malleolar region where microangiopathy is most intense. Over time Lesions may lichenify.2   It may arise as an early sign of chronic venous insufficiency but can persist or recur throughout all stages. Stasis Dermatitis is one of the most common causes of secondary dissemination of dermatitis and is therefore a complex and multifactorial condition.3

    In the Unani system of medicine, Stasis Dermatitis is not directly mentioned but it can be correlated with Nār FārsÄ« is characterized by dilute fluid-filled blackish vesicles having an erythematous or hyperpigmented base with thickened skin associated with extreme itching and burning. 4-7 The disease is not transmitted through the skin, it does, however, spread locally in its specific area. Severe itching, soreness, and vesicles are three prominent features of Nār FārsÄ« .8 Studies have estimated an approximately 6-7% prevalence of the condition in patients older than 50 years. A slight female preponderance has been reported in stasis dermatitis.9 In India it commonly affects people of low socioeconomic groups which often forces people to change occupations out of compulsion leading to adversity in the quality of life (QoL) of the individual.1 The main treatment of this disease in modern medicine includes compression of the veins by a firm elastic bandage or appropriate elastic stocking to control venous hypertension, the elevation of the leg, and mild topical corticosteroids to control eczema and itching. In patients with stasis dermatitis, there is poor compliance with compression therapy (Bandage/Stocking).10 Allergic contact dermatitis due to topically applied medicaments is a common complication of venous eczema.11

     In Unani medicine, Nār FārsÄ« is treated successfully with local and oral administration of single and compound drugs possessing properties like MuÊ»addil Ḍam, Mujaffif, Musakkin, Murakki, Muḥallil, and Mubarrid. Accordingly, Matbookh-e-Haleela along with Gil-e-Armani, sirka, and water and TaÊ»lÄ«q al-Ê»Alaq  (Leech Therapy) are selected to study their comparative efficacy.

Review of Literature:

     Stasis Dermatitis is a common component of the clinical spectrum of chronic venous insufficiency of the lower extremities. It may arise as an early sign of chronic venous insufficiency but can persist or recur throughout all stages and is often most prominent when ulcers are present. 3 Usually, this type of eczema starts around varicosities at the medial ankle, in the region of the Cockett perforating veins in the lower one-third of the leg. The eczema is relatively sharply demarcated and somewhat infiltrated with papules and vesicles, which may also extend beyond the main area of eczematous skin.12 The term “Stasis Dermatitis” was introduced by Pillsbury, and the term “Gravitational Dermatitis” by Belisario.3 The spectrum of Clinical presentation varies from localized mild leg dermatitis to widespread oozing dermatitis with eczematous spread. Stasis Dermatitis develops as an acute eczema or overtime as a subacute eczema or chronic eczema with scaling and itching over the ankle and lower leg. A patient has oedematous pitting on pressure, which is less noticeable in the morning but more easily seen towards the evening. There may be purpuric spots, hemosiderosis (seen as brownish part due to hemosiderin deposits) small atrophic scars (“Atrophic blanche”), and ulcers, all signs of venous hypertension.10 Clinical features depend on the stage of eczema: as in chronic eczema, there may be less exudation, prominent scaling, lichenification (a triad of hyperpigmentation, thickening of the skin, and increased skin markings), and fissuring in flexural lesions.4,13 The signs and symptoms of stasis eczema are assessed on the basis of the TSS visual analog scale (VAS) and EuroQol 5D scale. This is more feasible in obtaining a quick and simple understanding of the severity of the disease and response to medication. A study recommends using VAS, EuroQol 5D scale, and TSS to assess “Objective and subjective” disease severity measurement.14-16

      Chronic venous insufficiency (CVI) of the lower extremities is the cause of stasis syndrome. The venous flow up from the feet against gravity is made possible physiologically by the action of calf muscles and the competence of valves in the veins, this mechanism is defective in chronic venous insufficiency because of damage to the veins by thrombophlebitis or due to structural weakness of veins in the form of an incompetent valvular system. Because of incompetent valves, there blood reflux from the deep to the superficial veins, causing venous hypertension. Recent theories of CVI are related to the abnormal microcirculation leading to an inflammatory response.10 This commonly occurs in those who have to work in a stationary position for hours. Another explanation for cutaneous inflammation is the release of proteolytic enzymes and free radicals from sequestrated white blood cells in venules (due to venous hypertension), which produces tissue damage.10 Both microangiopathy and chronic inflammation are likely to be responsible for stasis dermatitis.3 Risk factors for chronic venous disease include heredity, age, female sex, obesity, pregnancy, prolonged standing, and greater height.2

     In the Unani system of medicine stasis eczema is not mentioned directly but its clinical features resemble with Nār FārsÄ«. Unani physicians have given detailed descriptions of Nār FārsÄ« including various modes of treatment.  Nar -e-Farsi is characterized by dilute fluid-filled blackish vesicles having erythematous or hyperpigmented base with thickened skin associated with extreme itching and burning.4-7 The disease is not transmitted through the skin, it does, however, spread locally in its specific area. Severe itching, soreness, and vesicles are three prominent features of Nār FārsÄ«.8 The etiology of Nār FārsÄ« is considered as khilá¹­ haad raqiq which is á¹¢afrāʼwÄ«  in nature, sometimes khilt sawdāʼ may present with it,5,17 excess in quality and quantity of khilá¹­ Dam is a causative factor as well.7,18 Madda causing Nār FārsÄ«   is thought to be Akkāl (corrosive), munafiq (vesiculant), Raá¹­b, and less infective 5

     The major aim of therapy in the management of venous hypertension, basic measures include the regular use of adequate compression bandages or stockings to improve venous return, lifestyle changes, and exercise of the calf muscles3  The legs should be elevated when the patient is resting, lying down or sleeping mild topical corticosteroids may be used to control eczema and itching for a short period.10 Despite all available therapies, recurrence, relapse, and chronicity of the disease is still a major problem in the management of eczema. On the other hand, long-term use of these medications has been linked to multiple local and systemic side effects. Therefore, it is essential to provide an alternative therapy that can provide not only effective, safe, and economical treatment but also can act for a longer duration, prevent recurrence, and should be free from adverse drug reactions. Unani medicine is a bounty of effective and safe drugs for several skin dermatoses and these drugs are time-tested. Since this disease is chronic, relapsing, and recurrent, Unani scholars incorporated a multidirectional approach where they recommended various treatment modalities like Ê»Ilāj biʼl Taghdhiya (dietotherapy), Ê»Ilāj biʼl TadbÄ«r (regimental therapy), and Ê»Ilāj biʼl Dawāʼ(pharmacotherapy) with several preventive measures.4 

    Management of Nār FārsÄ« includes the elimination of predisposing and aggravating factors, correction of environment and diet, systemic therapy, and local medication. The most important part is to reassure the patient that this disease is not contagious and is curable too. The procedure of Istifrāgh is used to remove khilá¹­ fasid (morbid materials). This khilá¹­ fasid should be removed from the body as they are detrimental 4,18 Before Istifrāgh, nudj must be provided by giving adwiyae mundij á¹¢afrā or Sawdā as per the need. Any of the following procedures for Istifrāgh can be utilized after the manifestation of nudj according to the corresponding khilá¹­ like TaÊ»rÄ«q (diaphoresis), Ishāl (purgation), Idrār (diuration) Qayʼ (purging), fasd (phlebotomy) hijama (cupping), irsal e alaq (leeching), tabreed wa tadeel (cooling and normalization) 19. First thing to do Istefrāgh Safrā by fasd, and then Islah-e-hazam to avoid constipation i.e describe treatment in unani literature Oral medication may include Advia MuÊ»addil Ḍam like shahitra, gul-e-surkh,Ushba,unnab,mundi,chobchini,chiraita,sarphooka,neem etc.17,20,21,22

Local application of Advia Mujaffif, Musakkin,murakkhi, Muhallil, Mubarrid is useful in acute eczema while Advia Muhallil,Mubarrid, and Muskkin in chronic eczema.6 A formulation of Matbookh-e-haleela ingredients for oral administration from Tibb e Akber and Gil-e-Armani and sirka with water for local application from classical unani text 20,23,24 and  TaÊ»lÄ«q al-Ê»Alaq for local application 19 is selected for stasis eczema to evaluate their efficacy

Objectives of the study:

To evaluate the comparative efficacy of Matbookh-e-Haleela with local application of Gil-e-Armani with sirka and water versus Leech therapy in Stasis Dermatitis

 


 
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