| CTRI Number |
CTRI/2025/12/098950 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic trial on toddlers bath. |
|
Scientific Title of Study
|
A randomised comparative clinical study to evaluate the dermal safety and efficacy of panchavalkala kashaya extract shower gel and himalaya gentle baby wash on the skin parameters of toddlers. |
| 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 Likhitha MV |
| Designation |
PG scholar Kaumarabhritya |
| Affiliation |
SDM Ayurveda college , hospital and research centre Udupi |
| Address |
Opd 11 ,Department Of Kaumarabhritya,Shri Dharmastala Manjunatheshwara College Of Ayurveda Hospital and Research centre Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
8618547470 |
| Fax |
|
| Email |
likhithamv536@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagaratna S Jartarghar |
| Designation |
Assosiate professor Kaumarabhritya |
| Affiliation |
SDM Ayurveda college ,Hospital and research centre Udupi |
| Address |
Opd 11 ,Department Of Kaumarabhritya,Shri Dharmastala Manjunatheshwara College Of Ayurveda Hospital and Research centre Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
8971518695 |
| Fax |
|
| Email |
nagaratnar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nagaratna S Jartarghar |
| Designation |
Assosiate professor Kaumarabhritya |
| Affiliation |
SDM Ayurveda college ,Hospital and research centre Udupi |
| Address |
Opd 11 ,Department Of Kaumarabhritya,Shri Dharmastala Manjunatheshwara College Of Ayurveda Hospital and Research centre Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
8971518695 |
| Fax |
|
| Email |
nagaratnar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Shree Dharmasthala Manjunatheshwara College Of Ayurveda And Research Centre Kuthpady Udupi -574118. Kaumarabhritya OPD-11. |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [(Nil)] |
|
|
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 Likhitha MV |
SHRI DHARMASTALA MANJUNATHESHWARA AYURVEDA HOSPITAL KUTHPADY UDUPI 574118 |
Opd 11 ,Department Of Kaumarabhritya,Shri Dharmastala Manjunatheshwara College Of Ayurveda Hospital and Research centre Kuthpady Udupi 574118
Udupi
KARNATAKA |
08618547470
likhithamv536@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICAL CLEARANCE COMMITTEE-HUMAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY TODDLERS |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: PANCHAVALKALA KASHAYA EXTRACT SHOWER GEL , Reference: ASTANGA HRIDAY UTTARA TANTRA 1ST CHAPTER, Route: Topical, Dosage Form: Kwatha/ Kashaya, Dose: 30(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: PANCHAVALKALA KASHAYA EXTARCT SHOWER GEL IS PREPARED AND USED QS | | 2 | Comparator Arm (Non Ayurveda) | | - | HIMALAYA GENTLE BABY WASH | HIMALAYA GENTLE BABY WASH IS COMPARED WITH PANCHAVALKALA KASHAYA EXTRACT SHOWER GEL |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
3.00 Year(s) |
| Gender |
Both |
| Details |
1 MEDICALLY STABLE TODDLERS WITH NO DERMATALOGICAL CONDITIONS AND WITH NO REQUIREMENT OF ANY OTHER DRUGS.
2 ADEQUATE FAMILY SUPPORT.
3 PARTICIPATING PARENT/GUARDIAN MUST BE WILLING TO NOT TO APPLY ANY OTHER BODY MOISTURIZER THROUGHOUT THE STUDY |
|
| ExclusionCriteria |
| Details |
1 TODDLER WITH HISTORY OF DERMATITIS,ECZEMA,PSORIASIS,DIAPER RASH WILL BE EXCLUDED.
2 TODDLER WITH HISTORY OF SKIN ALLERGY OR HYPERSENSITIVITY.
3 TODDLER WITH ACTIVE LOCALIZED OR GENERAL INFECTION INCUDING UPPER RESPIRATORY INFECTIONS.
4 TODDLER WITH A KNOWN CONDITION OF ASTHMA OR ANY RELATED BREATHING PROBLEMS.
5 CONDITION THAT MAY INTERFERE WITH EVALUATION OF TRIAL RESULTS,EG.,MEDICAL CHARACTERISTICS,DISEASES AND THERAPY THAT MAY INTERFERE WITH THE EFFECT OF INVESTIGATIONAL PRODUCT OR WITH THE EVALUATION OF EFFICACY OR SAFETY VARIABLES. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PANCHAVALKALA KASHAYA EXTRACT SHOWER GEL MAY BE MORE EFFECTIVE ON DERMAL SAFETY WHEN COMPARED TO HIMALAYA GENTLE BABY WASH. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PANCHAVALKALA KASHAYA EXTRACT SHOWER GEL MAY BE MORE EFFECTIVE ON SKIN PARAMETERS AND DERMAL OF TODDLERS WHEN COMPARED TO HIMALAYA GENTLE BABY WASH. |
30 DAYS |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
23/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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
|
According
to Evidence based guidelines for infant bathing Shower gels are
considered to be safe rather than bathing with water alone or by
using soaps in newborn and infants A mild liquid cleanser with water
is more effective than water alone at removing damaging substances
like faeces urine and food residues from skin surface So considering all these present study is planned where the kashaya
extract of Panchavalkala
drugs
will be made into shower gel form and it is designed to be mild and
nourishing keeping the toddlers skin clean soft and healthy when
used for bathing As Himalya gentle baby wash is ph balanced and prooven to be skin friendly hence a comparative study among these 2 is choosen
|