| CTRI Number |
CTRI/2025/04/084067 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of triphalabadriplakshadi kwath parisheka in the management of ahiputana(Diaper Rash) in children |
|
Scientific Title of Study
|
Randomised controlled clinical study to evaluate the efficacy of triphalabadriplakshadi kwath parisheka in the in management of ahiputana ( Diaper rash)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 |
DrJayshri Ram Motegaonkar |
| Designation |
MD scholar Kaumarbhritya |
| Affiliation |
Chhatrapati shahu Maharaj Shikshan sanstha |
| Address |
OPD No14 Balrog Department ,Chhatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidyala and Rugnalaya,Kanchanwadi,Paithan road,Chh Sambhajinagar
Aurangabad
MAHARASHTRA
431136
India |
| Phone |
7507888511 |
| Fax |
|
| Email |
motegaonkarjayshri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrK S Ratnaparkhi |
| Designation |
HOD and Professor |
| Affiliation |
chhatrapati shahu Maharaj shikshan Santhas |
| Address |
OPD No.14 Balrog department ,chhatrapati shahu Maharaj shikshan Santhas Ayurved Mahavidyalaya and Rugnalaya ,Kanchanwadi,Chh Sambhajinagar
Aurangabad
MAHARASHTRA
431136
India |
| Phone |
9421771722 |
| Fax |
|
| Email |
karunaratnaparkhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrK S Ratnaparkhi |
| Designation |
HOD and Professor |
| Affiliation |
chhatrapati shahu Maharaj shikshan Santhas |
| Address |
OPD No.14 Balrog department ,chhatrapati shahu Maharaj shikshan Santhas Ayurved Mahavidyalaya and Rugnalaya ,Kanchanwadi,Chh Sambhajinagar
Aurangabad
MAHARASHTRA
431136
India |
| Phone |
9421771722 |
| Fax |
|
| Email |
karunaratnaparkhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Ch.Sambhajinagar,Maharashtra,India,431136 |
|
|
Primary Sponsor
|
| Name |
DrJayshri Ram Motegaonkar |
| Address |
OPD NO.14 Balrog department,Chhatrapati Shahu Maharaj
Shikshan Santhas Ayurved Mahavidyalaya and Rugnalaya
Kanchanwadi, Paithan road, Chh.Sambhajinagar, Maharashtra,India, 431136 |
| 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 |
| DrJayshri Motegaonkar |
Chhatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidyalaya and Rugnalaya |
OPD No 14 Balrog Department ,Chhatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidyalaya and Rugnalaya ,Kanchanwadi ,Paithan Road ,Aurangabad,431011
Aurangabad
MAHARASHTRA |
9834108107
motegaonkarjayshri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CSMSS Ayurved Mahavidyalaya and Rugnalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: AHIPUTANA/AHIPUTANAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Zinc oxide | content 1)Active ingredient-zinc oxide 20% W/W-
-Skin Protectant
2)Inactive ingredient
Cetomacrogol1000,cetostearyl Alcohol,
light mineral oil, White soft paraffin
Action-It provides physical barrier to prevent skin irritation and help to heal damaged skin
Application-Local Application
Quantity-As per requirment | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphalabadariplakshtwak churna, Reference: AshtangSangrah Uttartantra 2/80, Route: Topical, Dosage Form: Churna/ Powder, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 10 Days, Reference: No, Route: -, Dosage Form: Churna/ Powder, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Month(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
1.Children diagnosed of Ahiputana(Diaper rash)with the presenting symptoms like strav,irritability,redness.
2.Symptoms of Ahiputana (Diaper rash)within 10 days.
3.Children in between the age group of 4 months to 2 year irrrespective of gender,socioeconomic religion, diet |
|
| ExclusionCriteria |
| Details |
1.Children above the age group of 2 year and below 4months
2.Children suffering from any other systemic disorder eg.acutegastroenteritis with dehydration,helmenthes infection,lactogen intolerance ,secondary infection.etc.
3.Symptoms of Ahiputana (Diaper rash) more than 10 days.
4.Children who have other generalised skin infections other than Ahiputana(Diaper rash) |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
strava(Discharge) will be decreased
Irritability(cry) will be decreased
Sthanik Varna (Erythema)will be decreased |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sthanik vyapti(region of rash) will be decreased |
10 days |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
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)
|
14/04/2025 |
| 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
|
1) Ahiputana (Diaper rash ) is a common in infants and very common feeding baby . it can be corelatted with diap-er rash disease whivh is kapharaktaj. 2) Predominant disorder mentioned in ayurvedik textbook 3) It comes under different types of Kshudrarog 4)It is caused due to unhygienic conditions like absence of proper cleaning after defecation and urination 5) Diaper rash is caused by B proteus in fecal matter. 6) In that diaper region inflammatory disorder characterized by the development of erythema, papules and sometimes vesiculation with scaling is seen diaper rash 7) It involves uppermost layer of the epidermis the stratum corneum and develops as a diapered skin. 8)The over hydration of skin promotes the development of higher PH than skin PH.Stool enzymes like protease and lipase have increased their activity which leads to increase in PH.and causes skin break down. In addition mechanical friction from the diaper cause skin break down.
PREVALANCE It is common dermatological disorder of infants resulting in a large number of visits to physician each year. the prevalence in infants has been estimated to be 4 to 35%
RATIONALE OF STUDY Diaper dermatitis is common frustrating disorder and occurs in children as the children can not telerate the pain or itching due to napkin rash so they cry for long time which hamper the mentality of parents. In this condition children are so irritable they avoid their daily food intake and results in weight loss of children. As skin of children is very sensitive, the conventional treatment in modern medicine has side effect such as allergic reaction, irritation , other skin diseases. So Ayurvedic medicine Triphalabadariplakshadi Kwath Parishek would be easy to follow, provide result in short duration and cost effective as well as easy for application and also free from side effects in managment of Ahiputana in children
NULL HYPOTHESIS(H0)- Triphalabadariplakshadi Kwath Parisheka is not effective in managment of Ahiputana in children.
ALTERNATE HYPOTHESIS(H1)-Triphalabadriplakshadi Kwath Parisheka is effective in managment of Ahiputana in children. |