| CTRI Number |
CTRI/2024/12/077970 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Shastika Shali bolus on facial pigmentation. |
|
Scientific Title of Study
|
Effect of Yashtimadhu Sneha with Modified Shastika Shali Pinda Sweda on facial skin pigmentation-A Standard Control Open Labelled Clinical Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chetali Kothari |
| Designation |
PG Student |
| Affiliation |
Padmashree Dr DY Patil Deemed to be University, School of Ayurveda. |
| Address |
DY Patil Ayurvedic Hospital, 1st floor ,Swasthavritta and yoga Department OPD No.- 6,Sector 7, Nerul east, Navi Mumbai
Maharashtra,India.
Thane
MAHARASHTRA
400706
India |
| Phone |
7892286232 |
| Fax |
|
| Email |
chetalik3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrudul Chitrakar |
| Designation |
Associate Professor |
| Affiliation |
Padmashree Dr DY Patil Deemed to be University, School of Ayurveda. |
| Address |
Padmashree Dr DY Patil Deemed to be University, School of Ayurveda, Sector 7, Nerul east, Navi Mumbai
Maharashtra,India.
Thane
MAHARASHTRA
400706
India |
| Phone |
9920071114 |
| Fax |
|
| Email |
mrudulmlonkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chetali Kothari |
| Designation |
PG Student |
| Affiliation |
Padmashree Dr DY Patil Deemed to be University, School of Ayurveda. |
| Address |
Padmashree Dr DY Patil Deemed to be University, School of Ayurveda, Sector 7, Nerul east, Navi Mumbai
Maharashtra,India.
Thane
MAHARASHTRA
400706
India |
| Phone |
7892286232 |
| Fax |
|
| Email |
chetalik3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Padmashree Dr DY Patil Deemed to be University, School of Ayurveda,
Sector 7, Nerul east,
Navi Mumbai,
Maharashtra - 400706
India.
|
|
|
Primary Sponsor
|
| Name |
Dr Chetali Kothari |
| Address |
Padmashree Dr DY Patil Deemed to be University, School of Ayurveda, Sector 7, Nerul east, Navi Mumbai,
Maharashtra-400706
India. |
| 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 Chetali Kothari |
DY Patil Ayurvedic Hospital |
Padmashree Dr DY Patil Deemed to be University, School of Ayurveda, 1st floor, Swasthavritta and yoga Department OPD NO. -6,
Sector 7, Nerul east,
Navi Mumbai,
Maharashtra - 400706
India.
Thane
MAHARASHTRA |
7892286232
chetalik3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DY Patil Deemed to be University, School of Ayurveda. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Skin Pigmentation |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Snehan , Swedan ,Lepan | (Procedure Reference: Vriddha Vaidhya Parampara, Procedure details: GROUP A - Abhyanga with Modified Shastika Shali Pinda Sweda
Pre procedure:
•Cleansing of face & neck region will be done with Go dughda (milk) for 2 minutes.
•Scrubbing (Utsadana) will be done with Madhu(honey) for 2 minutes.
Main procedure:
•Massage will be done with Yashtimadhu taila for 10 minutes by following scientific steps of massage for face & neck.
•The pottalis prepared will be dipped in warm mixture of kwatha & milk for few minutes & taken out.
•The massage will be done by pottalis uniformly in synchronized manner on face region in a circular direction.
•Duration:5 minutes
•Bolus bags will be opened & the paste will be applied (lepa) gently for 10 mins.
•Eyes will be covered with cotton dipped in rose water.
Post procedure:
•Cleaning of the face will be done by cotton dipped in normal water.
Total procedure time 30 mins
Abhyanga with Modified Shastika Shali Pinda Sweda for 30 minutes will be continued for 7 Days.
•The participants will be provided with Yashtimadhu fine powder & Yashtimadhu Taila.
•Study participant will apply Yashtimadhu taila daily & application of Yashtimadhu Churna along with milk in the form of lepa at least thrice a week for 3 weeks.
•The participants will be observed & assessed. Follow up will be taken on 7th ,14th ,21st ,30th day & assessment will be done.
•All skin care regimen & diet will be explained to the participants.
)
| | 2 | Comparator Arm | Procedure | - | Snehan (Mukha abhyanga) | (Procedure Reference: Ashtanga hrudaya, Procedure details: GROUP B (control group) - Kumkumadi taila
•Kumkumadi Taila application locally every night for 30 days
•Follow up on 7th,14th ,21st,30th day assessment will be done
All skin care regimen & diet will be explained to the participants
)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Only Female individuals
2.Aged 18 years - 40 years
3.Healthy individuals having pigmented skin due to sun exposure or post inflammatory pigmentation.
4.Participants willing to give written informed consent.
5.Participants willing to follow up.
|
|
| ExclusionCriteria |
| Details |
1.Participants not willing to participate in study
2.Participants with highly sensitive skin
3.Participants suffering from Active Acne, vitiligo, dermatitis.
4.Participants suffering from hyperpigmentation due to genetic or hormonal factors and melasma.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Yashtimadhu Sneha with Modified Shastika Shali Pinda Sweda on facial skin pigmentation |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To observe the difference in glow of facial skin.
2.To observe the effect on the complexion of overall facial skin
|
1 month |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="1"
Months="0"
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
|
|
Title
|
Effect of Yashtimadhu Sneha with Modified Shastika Shali
Pinda Sweda on facial skin pigmentation-A Standard Control Open
Labelled Clinical Study.
|
|
PG Scholar
|
Dr. Chetali
Kothari
|
|
Guide
|
Dr. Mrudul
Chitrakar
|
|
Study site
|
D.Y. Patil Deemed to be University, School of Ayurveda,
Nerul, Navi Mumbai-400706.
|
|
Study Design
|
Open labelled, standard control, randomised,
prospective clinical study.
|
|
Study
duration
|
30 days
|
|
Aim
|
To study the effect of Yashtimadhu
Sneha with Modified Shastika Shali Pinda Sweda on facial skin
pigmentation.
|
|
Objectives
|
- To observe the difference in glow of
facial skin.
- To observe the effect on the complexion of
overall facial skin.
- To introduce a natural novel procedure in
Ayurveda cosmetology.
- To assess the Quality of life.
|
|
Population to be studied
|
Healthy individual with
pigmented skin will be screened from Swasthya rakshan OPD and CAMPS conducted
by D.Y Patil University School of Ayurveda, Nerul, Navi Mumbai.
|
|
Sample size
|
GROUP A -36 participants (considering
20% dropout rate)
GROUP B -12 participants (considering
20% dropout rate)
|
|
Inclusion
criteria
|
- Only Female individuals
- Aged
18 years - 40 years
- Healthy individuals having pigmented skin
due to sun exposure or post inflammatory pigmentation.
- Participants willing to give written
informed consent.
- Participants willing to follow up.
|
|
Exclusion
criteria
|
- Participants not willing to participate in
study
- Participants with highly sensitive skin
- Participants suffering from Active Acne,
vitiligo, dermatitis.
- Participants suffering from
hyperpigmentation due to genetic or hormonal factors and melasma.
|
|
Efficacy
parameters
|
- Photographing
- Fitzpatrick scale
- Monk skin tone scale
- Dermatoscope
- Skin detector
|
|
Safety
parameters
|
Adverse events recording
|
|
Efficacy & Safety parameters Assessment
Schedule
|
- Photographing -V1,
V2, V3, V4, V5
- Fitzpatrick scale-V1,
V2, V3, V4, V5
- Monk skin tone scale-V1,
V2, V3, V4, V5
- Dermatoscope-V1, V2,
V3, V4, V5
- Skin detector- V1,
V2, V3, V4, V5
6. Physical
examination: will be done on V1, V2, V3, V4, V5
7. Quality of
Life Questionnaire V1 and V5
8. Questionnaire
after completion of treatment-V5
|
|
Statistical
Analysis
|
Inter-Group
Comparison: Mann-Whitney U test (for non-parametric data),
Unpaired t test (parametric data)
|
|
S.NO.
|
GROUPS
|
GROUP A
|
GROUP B
|
|
1.
|
PROCEDURE
|
Yashtimadhu Sneha Abhyanga +modified
Shastika Shali Pinda Sweda
|
Kumkumadi Taila
|
|
2.
|
ROUTE
|
Topical
|
Topical
|
|
3.
|
DURATION
|
30 days
|
30 days
|
|
4.
|
NO. OF PARTICIPANTS
|
36
|
12
|
|
5.
|
VISITS
|
1-7th day daily
|
1st day
|
|
6.
|
FOLLOW UP
|
7th day,
14th day,
21st day,
30th day,
|
7th day,
14th day,
21st day,
30th day,
|
|