| CTRI Number |
CTRI/2025/09/094686 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To assess the effect of Malati swarasa siddha taila in the management of hairfall caused due to application of hair cosmetics in the age group of 18-40 years. |
|
Scientific Title of Study
|
A crossover clinical study to compare the efficacy of Malati swarasa siddha taila and Coconut oil in the management of Khalitya in age group of 18-40 years |
| 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 KRISHNAKANT RATHI |
| Designation |
PG SCHLOAR |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,1st floor,Agadtantra department ,Sector no 25, Pradhikaran,Nigdi,Pune
At Post Shahapur, tal. khamgaon, dist Buldhana, Maharashtra
444303
Pune
MAHARASHTRA
411044
India |
| Phone |
7020482360 |
| Fax |
|
| Email |
krishnakantrathi8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santhy Thomas |
| Designation |
Professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,1st floor,Agadtantra department ,Sector no 25, Pradhikaran,Nigdi,Pune
PDEAs College of Ayurved and Research Centre,1st floor,Agadtantra department ,Sector no 25, Pradhikaran,Nigdi,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9663632312 |
| Fax |
|
| Email |
drsanthy07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SANTHY THOMAS |
| Designation |
Professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,1st floor,Agadtantra department ,Sector no 25, Pradhikaran,Nigdi,Pune
Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9663632312 |
| Fax |
|
| Email |
drsanthy07@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurveda and Research Centre, Nigdi,Pune, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Krishnakant Rathi |
| Address |
Sector no 25, Pradhikaran,Nigdi,Pune
Pune |
| 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 KRISHNAKANT RATHI |
Ayurved Rugnalaya and Snowbell Multispeciality Hospital |
visha chikitsa OPD, opd no. 117B, Nigdi, Pune
Pune
MAHARASHTRA |
07020482360
krishnakantrathi8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Standard Operating Procedure for Institutional Ethical Committee-I for Human Research at Pune District Education Associations College of Ayurved and Research Centre Pune |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Coconut oil, Reference: Nighantu ratnakar, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Malati swarasa siddha taila, Reference: SU. KA. 1/58, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: APPLYING HAIR OIL TO SCALP |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Volunteers having hair fall after use of any cosmetic haircare products |
|
| ExclusionCriteria |
| Details |
1.Volunteers with chronic illnesses, such as diabetes mellitus (DM), hypertension (HTN), autoimmune diseases, or hypothyroidism.
2. Pregnant and lactating women.
3. Patients on immunosuppressive drugs. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Malati Swarasa Siddha Taila and coconut oil within 15 days in managing Khalitya. |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe & explore the side effects & adverse reactions associated with the use of Malati Swarasa Siddha Taila & coconut oil. |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
22/09/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
MALATI SWARASA MENTIONED IN SUSRUTA KALPA STHANA IS MENTIONED FOR KESHSHATA (KHALITYA) SECONDARY TO THE EXPORE TO ANY VISHA. IN TODAYS ERA, VARIOUS APPLICATIPON OF HAIR COSMETICS LOADED WHICTH CHEMICALS WHICH ARE PROVEN TO CAUSE SCALP IRRITATION THEREBY CAUSING HAIRFALL. MALATI HAVING VISHAGHNA PROPERTIES AND COCONUT OIL BEING THE KESHYA IN NATURE CAN NEUTRALIZE THESE ACTIVITY OF THE VISHA AND CAN PROMOTE NEW HAIR GROWTH. THIS INNOVATIVE PREPARTION OF MALATI SWARASA SIDDHA TAILA BY MALATI SWARASA AND COCONUT WITH PROCEDURE MENTIONED IN SNEHAKALPANA ADHYAYA OF SHARANGDHAR SAMHITA CAN SHOW IMMPECABLE RESULTS FOR KHALITYA. HENCE THIS IS SELECTED FOR STUDY. |