| CTRI Number |
CTRI/2025/03/082159 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Preparation of Herbal Deodorant for hygiene in underarms |
|
Scientific Title of Study
|
A Clinical study To Evaluate the Effect of Ayurvedic Herbal Deodorant Shrigandha to Maintain Hygiene in Kaksha (underarms). |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AswathiM |
| Designation |
PG Scholar |
| Affiliation |
DY Patil School of Ayurveda, Nerul, Navi Mumbai |
| Address |
Department of Swasthavrtta,
OPD No. 06
DY Patil School of Ayurveda deemed to be university, Nerul, Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9444970448 |
| Fax |
|
| Email |
achuz2912doc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangala D Wange |
| Designation |
H.O.D and Professor |
| Affiliation |
DY Patil School of Ayurveda, Nerul, Navi Mumbai |
| Address |
Department of Swasthavrtta,
OPD No. 06
DY Patil School of Ayurveda deemed to be university, Nerul, Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9833359698 |
| Fax |
|
| Email |
mangala.wange@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
AswathiM |
| Designation |
PG Scholar |
| Affiliation |
DY Patil School of Ayurveda, Nerul, Navi Mumbai |
| Address |
Department of Swasthavrtta,
OPD No. 06
DY Patil School of Ayurveda deemed to be university, Nerul, Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9444970448 |
| Fax |
|
| Email |
achuz2912doc@gmail.com |
|
|
Source of Monetary or Material Support
|
| D.Y.Patil School of Ayurveda Nerul, Thane district,
Navi Mumbai
400706
India. |
|
|
Primary Sponsor
|
| Name |
AswathiM |
| Address |
Department of Swasthavrtta, OPD No. 06,
DY Patil School of Ayurveda, Deemed to be university, Nerul,
Thane district,
Navi Mumbai, India
400706. |
| 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 Aswathi M |
D.Y.Patil School of Ayurveda, Swasthyarakshan OPD |
Department of Swasthavrtta,
OPD No. 06,
D.Y.Patil School of Ayurveda, Nerul, Navi Mumbai - 400706
Thane
MAHARASHTRA |
09444970448
achuz2912doc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Approval Letter |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:3||Administration. Ayurveda Condition: SVEDAVAHA-SROTODUSHTI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Shrigandha, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Shrigandha is a deodorant to be applied in Kaksha (underarms) in sufficient quantity for 15 days twice daily. It is a localized topical application and hence the bhaishajya kala and anupana are not required. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy persons
2. Considering the VAS scales for sweat with Subjects between 2-8 scores will be selected.
3. Considering the VAS scale for itch with subjects between 1-7 will be selected.
4. Considering the Gradation for sweat smell with subjects between 2-5 will be selected.
|
|
| ExclusionCriteria |
| Details |
1. Subjects not willing to participate in study.
2. Subjects having diseases in axilla.
3. Subjects with the VAS scale of sweat ranging from 0-2 & 8-10 will be excluded.
4. Subjects with the VAS scale of itch
ranging from 0, 8-10 will be excluded.
5. Considering the Gradation for sweat smell
subjects between 0-1 will be excluded.
6. Subjects suffering from Hyperhidrosis secondary to any main disease is excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the Effect of Ayurvedic Herbal Deodorant "Shrigandha" to maintain Hygiene in Kaksha |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To Evaluate the Effect of Ayurvedic Herbal Deodorant “Shrigandha†to Maintain Hygiene in Kaksha (Underarms).
2.To assess the gradation for sweat production, itching in axilla and smell due to sweat.
3.To assess the quality of life.
4.To formulate and standardize the herbal deodorant from Ayurvedic herbs.
|
15 days |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/03/2025 |
| 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
|
Hygiene forms a crucial part of our health today. Sweating is a physiological condition of the body, and it helps regulate our body temperature. Sweat producing the foul smell, stain over the cloths and allergies/rashes are distressing and affects the people to avoid social contact with others because of embarrassment. Sweating over the armpits is a major issue. Hence, there is a negative impact on their social life, sense of wellbeing, emotional health and mental health and thus altogether makes a huge negative mark on the Quality of Life (QOL).According to Ch.Su.5th chapter, it explains the concept of Gandha Dravya and Maala Dhaarana. Promotional Benefits is it improves vitality, lifespan, nourishment and strength. Materials & Methods are herbal drugs Musta and Chirabilwa having antiperspirant as well as fragrant property is used and as per Sharangadhara Samhita Madhyama Khand 9/1-3, the siddha taila is prepared and the Shrigandha deodorant is prepared. Shrigandha deodorant will be used to check difference on the symptoms of hygiene in kaksha like excess sweat production, smell, itching by using the herbal deodorant. Results : The Shrigandha deodorant will bring a significant difference on the symptoms of hygiene in kaksha like excess sweat production, smell, itching by using the herbal deodorant. Keywords : Hygiene, quality of life, sweat, deodorant etc |