| CTRI Number |
CTRI/2025/09/094654 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Other (Specify) [therapeutic] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Unani treatment for Darkening of Neck and Armpits |
|
Scientific Title of Study
|
Efficacy of Joshanda Haleela Kabuli Orally with Tila Ushaq and Sirka vs Luaab e Hulba and Muqil topically in Fasad al Lawn ( Acanthosis Nigricans )-A Comparative Clinical Trial |
| 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 Sadiya Siddiqui |
| Designation |
PG Scholar |
| Affiliation |
Govt Unani Medical College and Hospital |
| Address |
Department of Amraze jild wa Tazeeniyat,Room no 8 Government Unani Medical College and Hospital,
Dr Siddaiah Puranik Road Basaveshwaranagar Bengaluru
Bangalore
KARNATAKA
560079
India |
| Phone |
8884296506 |
| Fax |
|
| Email |
Sadiyasayeed04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Ayesha Tabasum |
| Designation |
Professor and HOD |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Government Unani Medical College and Hospital,
Dr Siddaiah Puranik Road Basaveshwaranagar Bengaluru
Bangalore
KARNATAKA
560079
India |
| Phone |
9035158024 |
| Fax |
|
| Email |
ayesharafeeq81@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Ayesha Tabasum |
| Designation |
Professor and HOD |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Government Unani Medical College and Hospital,
Dr Siddaiah Puranik Road Basaveshwaranagar Bengaluru
Bangalore
KARNATAKA
560079
India |
| Phone |
9035158024 |
| Fax |
|
| Email |
ayesharafeeq81@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Opd 8 Government Unani Medical College and Hospital Bengaluru 560079 |
|
|
Primary Sponsor
|
| Name |
Government Unani Medical And Hospital |
| Address |
Dr Siddiaiah Puranik Road Basaveshwaranagar Bengaluru 560079 |
| Type of Sponsor |
Government medical college |
|
|
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 Sadiya Siddiqui |
Government Unani Medical College and Hospital |
OPD or IPD of Government Unani Medical College and Hospital
Dr Siddaiah Puranik Road Basaveshwaranagar Bengaluru
Bangalore
KARNATAKA |
8884296506
sadiyasayeed04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical Research, Government Unani Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L83||Acanthosis nigricans, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Haleela kabuli Terminalia Chebula orally Luaab e Hulba and Muqil topically |
Joshanda decoction is prepared by boiling 3gm of Haleela Kabuli soaked overnight in 100ml of water till it reduces to half of its volume 50ml then filter it 50ml of Joshanda e Haleela Kabuli will be administered orally before breakfast daily for 20 days in both the groups Required quantity of Hulba will be soaked overnight in water and luaab will be obtained then equal quantity of Muqil will be added and paste will be prepared Required quantity of Tila will be applied over the pigmented area once daily for 30 minutes for 30 days |
| Intervention |
Joshanda Haleela Kabuli (Terminalia chebula) orally
Ushaq and Sirka versus Luaab e Hulba and Muqil topically |
Efficacy of Joshanda Haleela Kabuli (Terminalia chebula) orally with tila Ushaq and Sirka versus Luaab e Hulba and Muqil topically in fasad al-lawn acanthosis nigricans- a comparative clinical trial |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between the age group 18 to 60 years.
Patients of all genders.
Patients clinically diagnosed with Acanthosis Nigricans on axilla and neck.
Known cases of Obesity PCOD Controlled DM.
Patients who are willing to sign the consent form for the trial.
|
|
| ExclusionCriteria |
| Details |
Patients with Uncontrolled DM RBS200mg/dl, HTN History of Malignancy.
Patients having history of Acanthosis Nigricans more than 5years.
Patients having history of using any topical application on pigmented areas or undergone any cosmetic procedure 1month prior to study.
Patients on any Hormonal treatment within 2months of study.
Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Changes in Dermoscopic findings in Acanthosis Nigricans.
2 Reduction in Burke scale score in Acanthosis Nigricans.
|
1 0th and 30th
2 0th,10th, 20th, 30th
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Felix von luschan indicates color changes.
2 Photographic changes. |
1 0th, 10th, 20th, 30th
2 0th and 30th |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="28"
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)
|
15/11/2025 |
| 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 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 - NO
|
|
Brief Summary
|
Acanthosis Nigricans Fasad al-Lawn is a skin disorder characterized by hyper- pigmentation and hyper keratosis of the skin. It is a cutaneous manifestation of underlying conditions which appears as a thick, velvety texture. It is characterized by poorly defined borders with velvety hyper- pigmented patch on the skin folds such as axilla,back of the neck, elbow, face, lips, soles of feet, and groin. The prevalence of Acanthosis Nigricans varies significantly, depending on age, ethnicity, skin type, degree of obesity, and concomitant diseases especially endocrinopathy, which can reach up to 25% in general surveys and above 60% in studies of overweight or obese children. Different epidemiological studies have reported its incidence of approximately 7% in general population and can be present up to 74% in obese people. Individuals with dark skin display this sign more commonly, with native Americans and African Americans being most commonly affected, followed by Hispanics, Asians, and much less Caucasians. In overweight or obese children, the ethnic influence on the prevalence rates appears less obvious. Occurrence of Acanthosis Nigricans increases with age and shows no gender difference. Although, the actual cause is unknown and it is most likely caused by factors that stimulate epidermal keratinocyte and dermal fibroblast proliferation. Acanthosis nigricans is a dermatological condition that primarily affects the skins appearance. It manifests in various forms, each associated with different underlying factors. This condition can serve as an important indicator of broader health issues. By identifying and addressing the root causes, individuals can take steps to enhance their overall well-being and quality of life. Currently, there is no optimal treatment for Acanthosis Nigricans available. The treatments we do have often come with side effects like redness, itching and burning sensations. As a result, there is a need to find more effective treatment option that minimizes these side effects, improving the overall experience and outcomes for individuals with this condition. In Unani classical literature Acanthosis Nigricans is termed as Fasad al- Lawn or Jild ka Mailapan which is caused by Sawdawi Madda. Unani system of medicine has extensive variety of arrangements asserting narratives adequacy in pigmentory issues of skin. The unani physicians recommended both single and compound formulations for the management of Fasad al -Lawn. Single drugs like Masoor, Baqla, Jau , Gond Babool, Neem pukhta chuwara, Unnab, Haleela siyah, kabuli etc.. and compound drugs like Itrifal Saghir, Matbookh e Aftimoon, Anar sheerein, Badam Sheerien Muqashar etc.. These drugs possess properties like Jali (detergent), Muhalil (resolvent), Muhammir (rubeficient), and Murattib (humidifying agent), Munzij (concoctive), Mushil (purgative),. However these drugs have not been scientifically explored so far. Hence, to evaluate the efficacy of one of the unani formulation Joshanda- e- Haleela Kabuli orally with Tila Ushaq and Sirka vs Luaab- e -Hulba and Muqil topically is designed to provide safe, more effective and economical treatment for Fasad al- Lawn. |