| CTRI Number |
CTRI/2024/10/075948 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| 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
|
Randomized controlled clinical study to evaluate the efficacy of Durvadi Lepa in Pama w.s.r. to Scabies in children. |
|
Scientific Title of Study
|
Randomized controlled clinical study to evaluate the efficacy of Durvadi Lepa in Pama w.s.r. to Scabies 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 |
Rushikesh Shivaji Dhobale |
| Designation |
PG SCHOLAR |
| Affiliation |
CSMSS AYURVED MAHAVIDYALAYA AURANGABAD |
| Address |
CSMSS Ayurved Mahavidyalaya and Rugnalaya 431002 Aurangabad Maharashtra India OPD No. 14, Balroga Department,CSMSS Ayurved Mahavidyalaya and Rugnalaya 431002 Aurangabad Maharashtra India Aurangabad MAHARASHTRA 431002 India |
| Phone |
7083548080 |
| Fax |
|
| Email |
rushikeshdhobale@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
KS Ratanparkhi |
| Designation |
HOD PROFESSOR |
| Affiliation |
CSMSS AYURVED MAHAVIDYALAYA AURANGABAD |
| Address |
CSMSS Ayurved Mahavidyalaya and Rugnalaya 431002 Aurangabad Maharashtra India OPD NO.14, Balroga DEpartment,CSMSS Ayurved Mahavidyalaya and Rugnalaya 431002, Aurangabad Maharashtra India. Aurangabad MAHARASHTRA 431002 India |
| Phone |
9421771722 |
| Fax |
|
| Email |
karunaratnaparkhi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
KS Ratanparkhi |
| Designation |
HOD PROFESSOR |
| Affiliation |
CSMSS AYURVED MAHAVIDYALAYA AURANGABAD |
| Address |
CSMSS Ayurved Mahavidyalaya and Rugnalaya 431002 Aurangabad Maharashtra India CSMSS Ayurved Mahavidyalaya and Rugnalaya 431002 Aurangabad Maharashtra India Aurangabad MAHARASHTRA 431002 India |
| Phone |
9421771722 |
| Fax |
|
| Email |
karunaratnaparkhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSMSS Ayurveda Mahavidyalaya, Kanchanwadi, Paithan Road, Aurangabad 431002. |
|
|
Primary Sponsor
|
| Name |
Rushikesh Shivaji Dhobale |
| Address |
CSMSS Ayurved Mahavidyalaya and Rugnalaya,Aurangabad 431002,Maharashtra,India |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CSMSS AYURVED MAHAVIDYALAYA |
CSMSS Ayurved Mahavidyalaya and Rugnalaya 431002 Aurangabad Maharashtra India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrRushikesh Dhobale |
CSMSS Ayurved mahavidyalaya |
OPD NO 14, Kaumarbhritya Deparment, CSMSS Ayurved Mahavidyalaya and Rugnalaya, Aurangabad 431002,Maharashtra India. Aurangabad MAHARASHTRA |
7083548080
rushikeshdhobale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chhtrapati Shahu Maharaj Sikshan Sanstha Institunal Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: PIDAKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Durvadi Lepa, Reference: Sharangdhar samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 20(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Premethrin 5% lotion | |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
children diagnosed as the case of pama
children having pama without secondary infection |
|
| ExclusionCriteria |
| Details |
patients suffering from any other systemic disorder congenital anomalies immune deficiency disorder and inborn errors of metabolism
kustha other than pama
pama with secondary infection |
|
|
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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| kandu,toda at day 1st,7th,14 |
Baseline 1st,7th ,14th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pitika varna , daha at day 1st,7th,14th |
Baseline 1st,7th ,14th |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
14/11/2024 |
| 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
|
Ayurveda is ancient medical science, which guide’s us about all
aspects of life in health and disease.
Kaumarbharitya, one among the ashtanga’s of ayurveda (8
branches of Ayurveda) has its recognition as important branch of
medicine as per Kashyapa.
Ayurveda has given importance to skin diseases since the era of
Vedas and later on Samhita kala. The study of skin disease were done
elaborately and separate chapter on Kushtha found the place. Skin disease in Ayurveda are described as Kushthroga disease.
There are seven MahaKushtha and eleven number of Shudra
Kushtharoga are explained. All Kushtharoga are Tridoshaja in nature
but according to dominancy of Dosha’s they can be classified
according to dosha.
Pama Kushtha is one of the ShudraKushtha, Which is
explained both in Brihatrayi and Laghutrayi. In Pama Pitta-Kapha is
dominating. It is contagious and widely spreader disease throughout
world. PamaKushtha is characterized by many small Pitika’s (ulcer),
Toda (pricking sensation),Daha(burning sensation) and Kandu
(itching).Pama may be considered as scabies in contemporary science.
Human scabies is intensely pruritic skin infection caused by the host
specific mite SARCOPTS SACABIEI HOMINIS. It is highly contagious,
neglected cutaneous parasite disease, associated with poor
individuals community, environmental circumstances and health. RATIONALE OF STUDY India is being a developing country, much population is
living in lower socioeconomic class more over 90% of population live
in rural area. Most of the Children’s are not conscious about their
health and personal hygiene which lead to many systemic diseases
like skin diseases, tuberculosis, cholera etc.{2}
Pama is highly contagious, intensively pruritic. It may
spread in a group of population within a short period of time due to
close contact or skin to skin contact and contaminated clothes.
It is found that "Pama" Vyadhi is one of the commonest
diseases found in the low socioeconomic class and occurs in person
do not follow guidelines of hygiene.
Sign, symptom, pathogenesis and treatment of Pama are
very well described in Ayurvedic texts which can correlate with
scabies in modern paediatrics. This indicates that disease is one of
the types of Kushtha. So far no study has been conducted for
evaluation of Durvadi lepa in above problem. Therefore, this study
was conducted to evaluate the efficacy of Durvadi lepa in the
management of Pama |