Taʻlīq al-ʻAlaq (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 NÄr FÄrsÄ« 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 NÄr FÄrsÄ« .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, NÄr
FÄrsÄ« is treated successfully with local and oral administration of single
and compound drugs possessing properties like Muʻaddil Ḍam, Mujaffif,
Musakkin, Murakki, Muḥallil,
and Mubarrid. Accordingly, Matbookh-e-Haleela along withGil-e-Armani, sirka, and water and Taʻlīq al-ʻAlaq (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 Dermatitisâ€
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 blancheâ€), 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 NÄr FÄrsÄ«.
Unani physicians have given detailed descriptions of NÄr FÄrsÄ« 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 NÄr FÄrsÄ«.8 The
etiology of NÄr FÄrsÄ« is considered as khilá¹ haad raqiq which is á¹¢afrÄʼwÄ«
in nature, sometimes khilt sawdÄʼ
may present with it,5,17 excess in quality and quantity of khilá¹
Dam is a causative factor as well.7,18 Madda causing NÄr
FÄrsÄ«is thought to be AkkÄl (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»IlÄj biʼl Taghdhiya
(dietotherapy), Ê»IlÄj biʼl TadbÄ«r (regimental therapy), and Ê»IlÄj
biʼl DawÄʼ(pharmacotherapy) with several preventive measures.4
Management of NÄr
FÄrsÄ« 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 IstifrÄghis used to
remove khilá¹ fasid (morbid materials). This khilá¹ fasid should be
removed from the body as they are detrimental 4,18 Before IstifrÄgh,
nudj must be provided by giving adwiyae mundij á¹¢afrÄ or SawdÄ
as per the need. Any of the following procedures for IstifrÄgh can be utilized
after the manifestation of nudj according to the corresponding khilá¹
like TaÊ»rÄ«q (diaphoresis), IshÄl (purgation), IdrÄr
(diuration) Qayʼ (purging), fasd (phlebotomy) hijama (cupping),
irsal e alaq (leeching), tabreed wa tadeel (cooling and
normalization) 19. First thing to do IstefrÄgh SafrÄ by fasd,
and then Islah-e-hazam to avoid constipation i.e describe treatment in
unani literature Oral medication may include Advia Muʻaddil 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 Taʻlīq al-ʻAlaq 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 versusLeech
therapy in Stasis Dermatitis