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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  
Name  Address 
NIL  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 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  
Status 
Not Applicable 
 
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. 
 
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.

 
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