| CTRI Number |
CTRI/2024/10/075626 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Application of Dhurdhooradi tailam and Keshyam oil in khalithya(Hairfall) |
|
Scientific Title of Study
|
A Comparitive Clinical Study On The Efficacy Of Dhurdhooradi Tailam And Keshyam Oil In Khalithya With Special Reference to Hairfall |
| 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 Viswalekshmi S |
| Designation |
Associate Professor |
| Affiliation |
Mannam Ayurveda Co operative Medical College |
| Address |
Department Of Shalakya Tantra Second Floor room no 319
Mannam Ayurveda Co operative Medical College Pandalam M S M PO Pandalam Pathanamthitta Pin 689501
Pathanamthitta
KERALA
689501
India |
| Phone |
9847588777 |
| Fax |
|
| Email |
visvalekshmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajith Kumar R |
| Designation |
Professor |
| Affiliation |
Shri Jagdishprasad jhabarmal tibrewala University |
| Address |
Department of Ayurveda
First floor Shri Jagdidhprasad jhabarmal tibrewala University Vidyanagari Jhunjhunu Churu Road Chudela Jhunjhunu Rajasthan 333010
Jhunjhunun
RAJASTHAN
333010
India |
| Phone |
8848384191 |
| Fax |
|
| Email |
ayudrajith@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Viswalekshmi S |
| Designation |
Associate Professor |
| Affiliation |
Mannam Ayurveda Co Operative Medical College |
| Address |
Department Of Shalakya Tantra Second Floor Room No 319 Mannam Ayurveda Co Operative Medical College Pandalam M S M PO Pandalam Pathanamthitta Pin 689501
Pathanamthitta
KERALA
689501
India |
| Phone |
09847588777 |
| Fax |
|
| Email |
visvalekshmi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mannam Ayurveda Co Operative Medical College MSM PO Pandalam Pathanamthitta Kerala Pin 689501 |
|
|
Primary Sponsor
|
| Name |
Mannam Ayurveda Co Operative Medical College |
| Address |
MSM PO Pandalam Pathanamthitta Kerala Pin 689501 |
| Type of Sponsor |
Other [Private Ayurveda 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 Viswalekshmi S |
Mannam Ayurveda Co Operative Medical College |
Department Of Shalakya Tantra Second Floor Room No 319 Mannam Ayurveda Co Operative Medical College Pandalam M S M PO Pandalam Pin 689501
Pathanamthitta
KERALA |
09847588777
visvalekshmi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Mannam Ayurveda Co operative Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:PCS||. Ayurveda Condition: KHALITYAM/KHALATI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Keshyam Oil, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: IN GROUP A -SUBJECTS OF KHALITHYA WILL BE TREATED WITH TOPICAL APPLICATION OF KESHYAM OIL(15ML) OVER THE SCALP FOLLOWED BY HEAD MASSAGE FOR 15 MINUTES FOR ONE MONTH | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dhurdhooradi Tailam, Reference: Sahasrayogam, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -IN GROUP B-SUBJECTS OF KHALITHYA WILL BE TREATED WITH TOPICAL APPLICATION OF DHURDHOORAPATRADI TAILAM(15ML) OVER THE SCALP FOLLOWED BY HEAD MASSAGE FOR 15 MINUTES FOR ONE MONTH |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects of age 15-50 years irrespective of Sex, Religion and Occupation
2.Subjects with classical signs and symptoms of Khalithya including Kandu, Keshachyuthi, Darunaka, Kesha sphutana.
|
|
| ExclusionCriteria |
| Details |
1.Patients below 15 years above 50 years
2.Patients with other skin disorders like scalp Psoariasis, Eczema etc
3.Patients with Thyroid disorders, Systemic and Autoimmune diseases.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in mean percentage of hairfall
To asses the effect of dhudhooradi taila and keshyam oil in khalithya |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in mean percentage of Kesha Sphutana,Darunaka |
30 days |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
N/A |
|
Date of First Enrollment (India)
|
28/10/2024 |
| 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="0"
Days="0" |
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
|
Hair makes our
body externally attractive and makes a person mentally and physically healthy.
In this present scenario because of busy life style, stress, polluted
environment, unhealthy diet and fast food it affects the hair and there is
increase in hairfall day by day. In ayurvedic classics hairfall is coined as
khalithya. Khalithya is mentioned in Ashtanga Hrudaya among 9 Kapala roga.
Now a days it is a common entity encountered in clinical practice.
Khalithya is a condition where it differs in vata and pitta prakruti. Dosha has
an important role in moulding the hair in varied natures. In ayurveda various
Bahya and Abhyantara chikitsa is described for Khalithya. A comparative
assessment of Dhurdhoora tailam and Keshyam oil in Khalithya is selected for
the study. Khalithya is a disorder where Shiroabhyanga is highly
beneficial.Shiroabhyanga act as a prophylactic and curative measure. The
aim of present study is to evaluate the efficacy of Durdooradhi Tailam and
Keshyam Oil in patients with diffuse hair loss.
Primary Outcome -
To evaluate the
reduction in the hairfall ensuring thicker and stronger growth
To evaluate the
reduction in keshakandu
Secondary outcome
To evaluate the
decrease in dandruff and kesha sphutana
|