| CTRI Number |
CTRI/2025/04/085591 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Assess the Ability of Triphaladi syrup and Triphaladi Malham w.s.r. to Diaper Dermatitis in children. |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy of Triphaladi Kashaya (Syrup) and Triphaladi Malham in the management of Ahiputna w.s.r. to Diaper Dermatitis in Children |
| 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 Karam Singh |
| Designation |
Lecturer, Department of kaumarbhritya |
| Affiliation |
RGGPG Ayurvedic College and Hospital, Paprola, Kangra, Himachal Pradesh |
| Address |
Room No. 218, Anatomy Block, RGGPG Ayurvedic College and Hospital, Paprola, Kangra, Himachal Pradesh Pandol Road, Teh-Baijnath, Distt.-Kangra, H.P.,Pin-176115 Kangra, Himachal Pradesh-176115, India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018708912 |
| Fax |
|
| Email |
Singhverma2024@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karam Singh |
| Designation |
Lecturer, Department of kaumarbhritya |
| Affiliation |
RGGPG Ayurvedic College and Hospital, Paprola, Kangra, Himachal Pradesh |
| Address |
Room No. 218, Anatomy Block, RGGPG Ayurvedic College and Hospital, Paprola, Kangra, Himachal Pradesh Pandol Road, Teh-Baijnath, Distt.-Kangra, H.P.,Pin-176115 Kangra, Himachal Pradesh-176115, India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018708912 |
| Fax |
|
| Email |
Singhverma2024@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vagisha |
| Designation |
MD Scholar |
| Affiliation |
Rajiv Gandhi Govt. Post Graduate Ayurvedic College, paprola, teh. Baijnath, distt. Kangra, H.P. |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Teh. Baijnath, Distt. Kangra, H.P.
RGGPG Ayurvedic College and Hospital, Paprola, Teh. Baijnath, Distt. Kangra, H.P., 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8219070980 |
| Fax |
|
| Email |
Vagishagarg786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Govt. Ayurvedic Pharmacy Paprola, Distt. Kangra, Herbal Garden and Herbarium, Research Institute in ISM, Jogindernagar, Distt. Mandi |
|
|
Primary Sponsor
|
| Name |
RGGPG Ayurvedic College |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Kangra, H.P. 176115 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Karam Singh |
RGGPG Ayurvedic College, Paprola |
Room No. 218, Anatomy Block, RGGPG Ayurvedic College and Hospital, Paprola, Kangra, Himachal Pradesh Pandol Road, Teh-Baijnath, Distt.-Kangra, H.P.,Pin-176115 Kangra, Himachal Pradesh-176115, India
Kangra
HIMACHAL PRADESH |
07018708912
Singhverma2024@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(HUMAN) RGGPG Ayurvedic College Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L22||Diaper dermatitis. Ayurveda Condition: AHIPUTANA/AHIPUTANAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphaladi kashaya, Reference: Sushrut chikitsa 20/58, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: 20 patients will be managed with triphaladi kashaya | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphaladi Malham, Reference: Sushrut chikitsa 20/58, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: -20 patients will be managed with triphaladi malaham |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
24.00 Month(s) |
| Gender |
Both |
| Details |
1. Patients between 1-24 months of age.
2. Full term baby, with a birth weight of more than 2500 grams.
3. Only mild to moderate patients of Diaper Dermatitis will be included.
4. Parents/Guardians of patient willing to participate in the research trial.
|
|
| ExclusionCriteria |
| Details |
1.Children above 24 months of age.
2. Any congenital anomaly of anal region which can lead to this cause.
3. Children suffering from any diseases like Tuberculosis, Malignancy, Diabetes mellitus etc.
4.Parents of patient not willing to participate in the trial.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulfillment of objective and subjective criteria in this clinical trial |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Control of Diaper Dematitis in
children. |
2 weeks |
|
|
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 2 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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 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
|
20 patients will be treated with Triphaladi kashaya with Triphaladi malham and other 20 patients are treated with Triphaladi malham to see the efficacy in Ahiputna w.s.r. to diaper dermatitis in children between 1-24 months of age group. |