| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E68||Sequelae of hyperalimentation. Ayurveda Condition: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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
|
“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 Dept. of Stri roga and Prasuti tantra Amrita School of Ayurveda, Amritapuri, Amrita Vishwa Vidyapeetham, India. |