| CTRI Number |
CTRI/2023/03/050493 [Registered on: 09/03/2023] Trial Registered Prospectively |
| Last Modified On: |
03/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effects of a Unani formulation in patients with Acne. |
|
Scientific Title of Study
|
Evaluating the therapeutic effects of a Unani Formulation of Lattukh (smear) in the management of Buthur Labaniyya (Acne vulgaris): A single blind, randomized, standard control study.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahvish Mehraj |
| Designation |
PG Scholar |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM), Srinagar |
| Address |
Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir
Srinagar JAMMU & KASHMIR 190006 India |
| Phone |
7006565905 |
| Fax |
|
| Email |
mehvishmehraj8@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Zaffar Hussain |
| Designation |
Professor and HOD Department of Moalajat |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM), Srinagar |
| Address |
Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir
Srinagar JAMMU & KASHMIR 190006 India |
| Phone |
7006021996 |
| Fax |
|
| Email |
hussainzaffar6@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Zaffar Hussain |
| Designation |
Professor and HOD Department of Moalajat |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM), Srinagar |
| Address |
Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir
Srinagar JAMMU & KASHMIR 190006 India |
| Phone |
7006021996 |
| Fax |
|
| Email |
hussainzaffar6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine New Delhi |
| Address |
Regional Research Institute of Unani Medicine (RRIUM),University of Kashmir, Srinagar, CCRUM New Delhi |
| Type of Sponsor |
Research institution |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mahvish Mehraj |
Regional Research Institute of Unani Medicine |
Moalajat OPD-1, Ground floor, Department of Moalajat, RRIUM, Naseembagh Campus University of Kashmir Hazratbal Srinagar JAMMU & KASHMIR |
7006565905
mehvishmehraj8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RRIUM Srinagar |
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: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clindamycin |
Clindamycin 1% shall be applied locally over affected areas at bedtime for 40 days. |
| Intervention |
Lattukh (Smear) |
It is a classical Unani formulation taken from Canon of Medicine. The formulation comprises of Injir (Ficus carica Linn) (dried fruit), Kalonji (Nigella sativa) (seeds) and Sirka [Sirka angoori ( Grape vinegar)]. The formulation shall be applied locally over affected areas at bedtime for 40 days. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of age between 12-40 years.
2) Patients with mild to moderate forms of acne.
3) Irrespective of gender.
4) Patients with itching, erythema, comedones,
papules and pustules.
5) Patients who are willing to give consent and
are able to follow up.
|
|
| ExclusionCriteria |
| Details |
1) Patients below 12 years and above 40 years of
age.
2) Patients with severe forms of acne.
3) Diagnosed patients of PCOS.
4) Pregnant and lactating women.
5) Patients on corticosteroid therapy and on
OCP’s.
6) Patients suffering from systemic illnesses like
Cardiovascular disease, chronic kidney disease
and chronic liver disease, thyroid disease or
malignancy.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Change from baseline to day 41st in the inflammatory (Papules and pustules) lesions and non-inflammatory (open and closed comedones) lesions (GAGS- Global Acne Grading System).
2) Change from baseline to day 41st in Investigator’s Global Assessment of Acne (IGA).
3) Change from baseline to day 41st day in the inflammatory (papules and pustules) lesions
based on photographs of lesions.
4) Change from baseline to day 41st day in the quality of life of subjects based on the Dermatology Life Quality Index (DLQI).
|
40 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Effect on itching based on Visual Analogue Scale (VAS).
2) Effect on redness based on Clinical Erythema Assessment (CEA).
3) Effect on eruptions based on Simple Grading System by Indian Authors. |
40 Days. |
|
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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 |
|
Date of First Enrollment (India)
|
10/03/2023 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acne vulgaris is a common skin condition characterized by comedones, inflammatory lesions
like papules, pustules, nodules and cysts; and scars mainly on face, chest and upper back. The
prevalence of Acne vulgaris is believed to be 85% among teenagers and young adults,
making it one of the most prevalent skin diseases worldwide. The lesions disappear in the
third decade of life in roughly 70% of patients. Both the genders are equally affected;
however, men are roughly ten times more likely to develop nodulocystic acne. A lot of
mental issues are frequently linked to have a relatively disfiguring skin condition during a
time when a person is developing his social identity. Acne vulgaris is a major contributor to
psychosocial and psychological impairment in young people, causing anxiety and mood
disorders and lowering self-esteem, even though it is not life threatening. The incidence of
Acne vulgaris appears to be increasing globally. Acne vulgaris has been recognized and
described by various Unani physicians. It has been described as small, white lesions on the
nose and cheeks, resembling droplets of condensed milk and as the lesions mature and
develop fully, they exude peep (pus). The Madda-i-á¹¢adidiya (infected matter) that causes
these lesions is brought to the skin surface by the bukarat-i-badan (body vapours) and the
condition is treated with drugs having Tajfif (desiccant) and Tahlil (resolving) properties. The
formulation of Lattukh (smear) consists of Injir (Ficus carica Linn), Kalonji (Nigella sativa)
and Sirka ( Grape vinegar) and all the three drugs possess the above mentioned properties. In
contemporary system of medicine, there are many treatment modalities available but all have
side effects, and pose an economical burden and some people don’t respond well to them.
The management of Acne vulgaris depends on its severity and subtype. Topical medications
like benzoyl peroxide, retinoids, and topical antibiotics can be used to combat mild to
moderate forms of Acne vulgaris, however, each of them develops side effects like xerosis,
erythema, skin irritation such as itching, burning and stinging sensation. Oral antibiotics like
tetracyclines, macrolides and clindamycin can be used with topical medications to alleviate
moderate to severe forms of Acne vulgaris but have associated detrimental effects such as
nausea, vomiting or diarrhoea, abdominal pain; hypersensitivity reactions (pneumonitis,
eosinophilic nephritis, serum sickness), autoimmune disorders (SLE, autoimmune hepatitis,
polyarthritis nodosa), dizziness, headache, and photosensitivity associated with tetracyclines.
Acne vulgaris in females can be treated with hormonal therapy, such as spironolactone or
combination oral contraceptives. Isotretinoin, a systemic retinoid, is the treatment of choice
for severe nodulocystic acne. Although it is quite successful, it can have major detrimental
effects, such as teratogenicity and psychiatric side effects, and it needs to be closely
monitored. The necessity to authenticate the activity of Unani drugs, which are safe, effective, and have limited side effects, emerges in view of aforementioned facts in order to
cure the condition and enhance the quality of life. |