FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/070930 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 24/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Process of Care Changes 
Study Design  Single Arm Study 
Public Title of Study   Pre And Post Clinical Study To Evaluate The Effect Of External Application Of Kusumbha Taila In The Management Of Hirsutism 
Scientific Title of Study   A Single Arm Pre And Post Clinical Study To Evaluate The Effect Of External Application Of Kusumbha Taila In The Management Of Hirsutism 
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 Ahana Salim 
Designation  1st year PG Scholar 
Affiliation  Amrita School Of Ayurveda 
Address  Department of Striroga and Prasuti Tantra Amrita School Of Ayurveda Amrita Viswa Vidyapeetham Amritapuri Clappana P O Kerala India

Kollam
KERALA
690525
India 
Phone  8075225422  
Fax    
Email  ahanasalim147@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ahana Salim 
Designation  1st year PG Scholar 
Affiliation  Amrita School Of Ayurveda 
Address  Department of Striroga and Prasuti Tantra Amrita School Of Ayurveda Amrita Viswa Vidyapeetham Amritapuri Clappana P O Kerala India

Kollam
KERALA
690525
India 
Phone  8075225422  
Fax    
Email  ahanasalim147@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Hemavathi S K 
Designation  Professor and HOD 
Affiliation  Amrita School Of Ayurveda 
Address  Department of Striroga and Prasuti Tantra Amrita School Of Ayurveda Amrita Viswa Vidyapeetham Amritapuri Clappana P O Kerala India

Kollam
KERALA
690525
India 
Phone  8075225422  
Fax    
Email  hemavathi@ay.amrita.edu  
 
Source of Monetary or Material Support  
Amrita School Of Ayurveda Amrita Viswa Vidyapeetham Amritapuri Clappana P O Kerala India 690525 
 
Primary Sponsor  
Name  Dr Ahana Salim 
Address  Department of Striroga and Prasuti Tantra Amrita School of Ayurveda Amrita Viswa Vidyapeetham Amritapuri Clappana P O Kerala India 690525 
Type of Sponsor  Other [Self] 
 
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 Ahana Salim  Amrita School of Ayurveda   Striroga and Prasuti Tantra OPD Department of Striroga and Prasuti Tantra Amrita School Of Ayurveda Amrita Viswa Vidyapeetham Amritapuri Clappana P O Kerala India 690525
Kollam
KERALA 
8075225422

ahanasalim147@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Amrita School Of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E68||Sequelae of hyperalimentation. Ayurveda Condition: MUKHAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Kusumbha Taila, Reference: Bhaishajya Ratnavali 60th chapter 175th shloka, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Subjects presented with complaints of facial hair with the score between 1 – 12 in modified Ferriman- Gallwey Score scale.
Patient without any menstrual irregularities
Age group between 18-45 years
Humidity related hyper androgenism and familial hyperandrogenism like conditons will be included  
 
ExclusionCriteria 
Details  Pregnant and Lactating women
Diagnosed cases of hypersensitive skin
women choose not to abstain from using creams or oils.
Patient with any menstrual irregularities  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in extent of hair growth using modified Ferriman-Gallwey Scoring.
Reduction in the density of hair using ImageJ software.
Reduction in the hair count using Dermatoscope.  
1st day and 45th day 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="31"
Sample Size from India="31" 
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)   28/07/2024 
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="5" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

PROPOSED TITLE – 

“A SINGLE ARM PRE AND POST CLINICAL STUDY TO EVALUATE THE EFFECT OF EXTERNAL APPLICATION OF KUSUMBHA TAILA IN THE MANAGEMENT OF HIRSUTISM” 

DURATION OF THE STUDY – 45 days per Subject 

Hirsutism is defined as the presence of terminal hair with male pattern distribution in women. It is the main manifestation of hyperandrogenism in women, with a prevalence estimated at 65–75%, While in the general population, hirsutism affects around 4–11% of women and is the most common complaint presenting in the department for cosmetic reasons. Sex steroids and a number of local and systemic factors like humidity , temperature can act directly and indirectly on the dermal papilla to regulate hair growth. In response to the increased levels of androgens at puberty, vellus follicles in specific areas develop into terminal hairs. Androgens increase hair follicle size, hair fiber diameter, the proportion of time terminal hairs spend in the anagen phase and sebum secretion. Therefore, not only does androgen action alter the type of present hair, but also they will increase the oiliness of skin and hair.  The Social stigma associated with hirsutism due to psychological stress, economic loss, isolation and inferiority complex will lead to a reduction in Quality of Life. Thus, there is a necessity for better and cost-effective management, which will  reduce the severity of hirsutism.Even though various lomashatana yoga are mentioned in Kashyapa Samhitha, no toxicity studies have been conducted so far to prove the effect of herbo-mineral formulations in the management of hirsutism .It is found that  Kusumbha Taila ,  mentioned in Bhaishajya Ratnavali , has lomashatana effect, and  studies have been conducted to evaluate the safety use of Kusumbha taila.In literary search, no studies employing a validated tool for hirsutism have been conducted to substantiate the effect of classical formulations. 

 

ESTIMATED COST –33,800 Rs approximately 

Dr Ahana Salim 

First Year P.G. Scholar 

Dept. of Stri roga and Prasuti tantra  

Amrita School of Ayurveda, Amritapuri, 

Amrita Vishwa Vidyapeetham, India. 

 

 
Close