| CTRI Number |
CTRI/2023/07/054975 [Registered on: 10/07/2023] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study Of Arkamanahshiladi Taila In Scabies Of Children |
|
Scientific Title of Study
|
A Controlled Clinical Study Of Arkamanahshiladi Taila In Pama Kushtha (Scabies) In Children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Smriti Sajwan |
| Designation |
P G Scholar |
| Affiliation |
Uttrakhand Ayurveda University Gurukul Campus Haridwar |
| Address |
OPD no 9, PG Department of Kaumarbhritya, Uttarakhand Ayurveda University Gurukul Campus Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
7895485457 |
| Fax |
|
| Email |
smritisajwan26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr GP Garg |
| Designation |
Professor And HOD |
| Affiliation |
Uttrakhand Ayurveda University Gurukul Campus Haridwar |
| Address |
OPD no 9, PG Department of Kaumarbhritya, Uttarakhand Ayurveda University Gurukul Campus Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9411178353 |
| Fax |
|
| Email |
drgarggp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr GP Garg |
| Designation |
Professor And HOD |
| Affiliation |
Uttrakhand Ayurveda University Gurukul Campus Haridwar |
| Address |
OPD no 9, PG Department of Kaumarbhritya, Uttarakhand Ayurveda University Gurukul Campus Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9411178353 |
| Fax |
|
| Email |
drgarggp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttarakhand Ayurveda University, Gurukul Campus Haridwar |
|
|
Primary Sponsor
|
| Name |
Registrar Uttarakhand Ayurveda University |
| Address |
Uttarakhand Ayurveda University, Gurukul Campus, Haridwar |
| Type of Sponsor |
Other [Uttarakhand Ayurveda University, Gurukul Campus, Haridwar] |
|
|
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 |
| smriti sajwan |
Uttarakhand Ayurveda University Gurukul campus haridwar |
OPD no 9, PG Department of Kaumarbhritya, Uttarakhand Ayurveda University Gurukul Campus Haridwar
Hardwar
UTTARANCHAL |
7895485457
smritisajwan26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Uttarakhand Ayurveda University Gurukul Campus, Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B86||Scabies. Ayurveda Condition: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Arkamanahshiladi taila, Reference: Chakradatta, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 15 Days, Reference: No, Route: -, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Permethrin5% | Dose- Local thin layer Application at bedtime on the affected area.
Age group-3-16 years |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of age group 3-16 years irrespective of sex, locality and socioeconomic status.
2. Patients having classical symptoms of Pama kushtha i.e. kandu (itching), Shweta, Arun, Shyawa, Kandu Yukta Pidika, Daha, Srava.
|
|
| ExclusionCriteria |
| Details |
1.children below 3 years and above 16 will be excluded.
2.Patient suffering from any other acute or chronic, systemic or local disorders like Psoriasis, Tuberculosis, Leprosy, Dermatitis etc.
3.Immune deficiency disorders.
4.Superadded infection.
5.Norwegian scabies (crusted scabies)
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
relief in subjective parameters like-
1.Kandu ( Itching)
2.Pidika (Burrows)
3.Daha (Burning sensation)
4.Shrava (Discharge)
5.Toda (Pain)
6.Bahvya sphika paani kurpare pitika (Symptoms most often found On buttocks, Hands, elbows region) |
At 1st day, 5th day , 10th day,15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
relief in subjective parameters like-
1.Kandu ( Itching)
2.Pidika (Burrows)
3.Daha (Burning sensation)
4.Shrava (Discharge)
5.Toda (Pain)
6.Bahvya sphika paani kurpare pitika (Symptoms most often found On buttocks, Hands, elbows region) |
15th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/07/2023 |
| Date of Study Completion (India) |
18/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
AYURVEDIC PERSPECTIVES ON MANAGING PAMA KUSHTHA (SCABIES) IN
CHILDREN: A COMPREHENSIVE REVIEW,IAMJ
http://www.iamj.in/posts/images/upload/434_439.pdf |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a randomized open-level controlled clinical trial to determine the efficacy of Arkamanahshiladi taila in Pama (scabies) for the group between 3-16 years daily for 15 days. The study will be conducted at UAU, Gurukul Campus, Haridwar in 30 patients.
The assessment will be done on the basis of subjective parameters. The study will be conducted at the OPD/IPD level of the P.G. Department of Kaumarbhritya. The study assessment will be done At the registration, 5th day, 10th day, and 15th day of the clinical trial and the result obtained will be tabulated and statistically analyzed using appropriate tests. |