| CTRI Number |
CTRI/2021/03/032083 [Registered on: 17/03/2021] Trial Registered Prospectively |
| Last Modified On: |
16/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Decoction of Cuscuta Reflexa and local application of Saussurea Lappa and Honey in the management of Melasma. |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Safety and Efficacy of Joshanda(Decoction) of Aftimoon(Cuscuta Reflexa Roxb) and Topical Application of Qust(Saussurea Lappa Clarke) with Honey in the Management of Kalaf(Melasma). |
| Trial Acronym |
|
|
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 |
Pg Scholar |
| Affiliation |
Regional Research Institute of Unani Medicine |
| Address |
Department of Moalijat, RRIUM, Naseem Bagh Campus University of Kashmir, Hazratbal, Srinagar.
Srinagar JAMMU & KASHMIR 190006 India |
| Phone |
9419421375 |
| Fax |
|
| Email |
tabasumhakeem81@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shameem Ahmad Rather |
| Designation |
Reader |
| Affiliation |
Regional Research Institute of Unani Medicine |
| Address |
Department of Moalijat, RRIUM, Naseem Bagh Campus University of Kashmir, Hazratbal, Srinagar.
Srinagar JAMMU & KASHMIR 190006 India |
| Phone |
7889584083 |
| Fax |
|
| Email |
shameem.rather.sr@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shameem Ahmad Rather |
| Designation |
Reader |
| Affiliation |
Regional Research Institute of Unani Medicine |
| Address |
Department of Moalijat, RRIUM, Naseem Bagh Campus University of Kashmir, Hazratbal, Srinagar.
Srinagar JAMMU & KASHMIR 190006 India |
| Phone |
7889584083 |
| Fax |
|
| Email |
shameem.rather.sr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council Of Research in Unani Medicine, New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council of 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 |
|
|
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 |
Regional Research Institute of Unani Medicine Srinagar |
Moalijat OPD-1, Ground Floor, Department of Moalijat Srinagar JAMMU & KASHMIR |
9419421375
tabasumhakeem81@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RRIUM, Srinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L811||Chloasma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Joshanda(Decoction) of Aftimoon(Cuscuta Reflexa) and Topical application of Qust(Saussurea Lappa) and Honey. |
Aftimoon(Cuscuta Reflexa) 5 gm in the form of decoction shall be prepared as per standard procedure and shall be given once a day after breakfat. And Zimad or paste of Qust(Saussurea Lappa) shall be made by grinding and mixing it with sufficient quantity of honey. To be applied locally at bedtime.
Duration: 60days |
| Comparator Agent |
Tranexamic Acid orally and Azelaic Acid cream locally |
Tranexamic Acid 250 mg orzlly twice a day after lunch and dinner.
Azelaic Acid 10% cream to be applied at bed time.
Duratin 60 days. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
The following patients will be included:
1.Clinically diagnosed patients of Kalaf.
2.Irrespective of all genders.
3.patients between the age of 15 to 50 years. |
|
| ExclusionCriteria |
| Details |
The following patients will be excluded:
1.Patients with history of Cardiovascular,Endocrine, Renal and Liver Diseases.
2.Skin sensitivity by history and clinical examination.
3.Pregnancy, Lactation and patients on oral contraceptives.
4.Patients on Anticoagulants. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of the hyperpigmentation spots in Melasma. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heamatological and biochemical evaluation for safety. |
60 days |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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)
|
22/03/2021 |
| 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 |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Kalaf (Melasma) is a common, chronic, accquired pigmentary disorder characterized by symmetric reticulated hyper pigmentation with irregular margins on the sun exposed areas of the face and rarely on the upper chest and extremities. It oocurs in all races and and ethnic groups, but is more prevelant in women and those people with Fitzpatrick skin type IV-VI and also in Hispanics, Asians and Africans. It occurs in 60% of pregnant women and 30% of women on oral contraceptive pills. The prevalance of melasma is 1.5%-33.3% globally. The most commonly affected age group is between 30-55 years, but rarely it can occur during puberty and post menopausal period.
Kalaf is described in all classical Unani textbooks like Al-Qanoon, Kamil-us- Sanah, Al-Havi, Al-Moalijat-al-Buqratiya etc. It is caused due to morbid matters especially sauda(black bile) under th skin. Thus it is treared by Istefragh (Evacuation) of black bile for which oral drugs are given, and also topical application of Jali(Clensing), Qabiz(Astringent), Muhammir(Rubefacient) drugs are given to treat Melasma. In allopathic system of medicine different treatment modalities are used in treatment of Kalaf, like topical drugs eg Hydroquinone, Azelaic acid, Kojic acid, oral drugs eg, Tranexamic acid, Glutathione etc and many procedural therapies eg microneedling, chemical peeling etc. All these treatments have numerous side effects like redness, irritation, allergy,burns,headache,abdominal bloating etc. Topical therapy is often insufficient to clear melasma causing many side effects also high relapserates after discontinuation of the treatment. This disease even though has no impact on general health it is associated with social stigma and has negative impact on quality of life. Keeping in view the above factors the present study is designed. |