| CTRI Number |
CTRI/2025/01/079155 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Reduction in sweating of palms by internal and external use of Panchatiktha gritha. |
|
Scientific Title of Study
|
Effect of Panchatiktha gritha internally and externally in Primary palmar hyperhidrosis |
| 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 Athira T |
| Designation |
PG Scholar, Department of Kayachikitsa |
| Affiliation |
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital |
| Address |
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital, Cheruthuruthy, Thrissur
Thrissur
KERALA
679531
India
Thrissur
KERALA
679531
India |
| Phone |
8943601943 |
| Fax |
|
| Email |
ahira.athira@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ratheesh P |
| Designation |
HOD and Professor, Department of Kayachikitsa |
| Affiliation |
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital |
| Address |
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital, Cheruthuruthy, Thrissur
Thrissur
KERALA
679531
India
Thrissur
KERALA
679531
India |
| Phone |
9846889793 |
| Fax |
|
| Email |
drrpnair07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinitha C |
| Designation |
Associate Professor, Department of Kayachikitsa |
| Affiliation |
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital |
| Address |
Poomulli Neelakandan Nmboodiripad Memorial Ayurveda Medical College and Hospital,Cheruthuruthy, Thrissur
Thrissur
KERALA
679531
India
Thrissur
KERALA
679531
India |
| Phone |
9497062425 |
| Fax |
|
| Email |
drvinithasujith@gmail.com |
|
|
Source of Monetary or Material Support
|
| Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital Cheruthuruthy, Shoranur 679531
KERALA |
|
|
Primary Sponsor
|
| Name |
Athira T |
| Address |
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital |
| 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 Athira T |
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital |
Department of Kayachikitsa
Room number 01
Cheruthuruthy
Shornur
Thrissur
679531
Kerala
India
Thrissur
KERALA |
8943601943
ahira.athira@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PNNM Ayurveda Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L745||Focal hyperhidrosis. Ayurveda Condition: SVEDAVAISHAMYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchatiktha gritha, Reference: Sarangadhara samhitha, Route: Oral, Dosage Form: Ghrita, Dose: 12(g), Frequency: hs, Bhaishajya Kal: Antarabhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushnambhu), Additional Information: Panchatiktha gritha is indicated for palmar sweating in Malayalam text-Yogaratna samuchaya | | 2 | Intervention Arm | Procedure | - | अभ्यंग | (Procedure Reference: yogaratnasamuchayam, Procedure details: after cleaning the palmar surface of the hand sufficient quantity of ghee is applied on the palmar
surface at bedtime for 30 minutes)
(1) Medicine Name: panchatiktha gritham, Reference: yogaratnasamuchayam, Route: Topical, Dosage Form: Ghrita, Dose: 5(g), Frequency: hs, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Participants fulfilling the diagnsotic criteria
Participants willing to give informed consent |
|
| ExclusionCriteria |
| Details |
Participants with secondary hyperhidrosis
Participants with congenital primary palmar hyperhidrosis
Participants who are known cases of any systemic illness
Participants who are known case of psychiatric illness
Pregnant and lactating woman
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
subjective parameter
HDSS
Objective parameters
visual scale- minors test
gravimetry
objective parameter
Visual scale- Minors test
Gravimetry |
0th 31st 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HidroQOL |
0th 31st 45th day |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Research topic is Primary palmar hyperhidrosis.This interventional study aims to find the etiological factors as well as a medicinal cure for the same. There are two mode of intervention- internal and external. Drug chosen in Panchatiktha gritha which is indicated for the same condition in malayalam textbook, Yogaratna samuchaya. Assessment will be done on 0th, 31st and 45th day. |