| CTRI Number |
CTRI/2024/08/071839 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2024 |
| 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
|
Clinical trial to study the effect of Rajikushthadi Lepa in pama with special reference to scabies |
|
Scientific Title of Study
|
Randomised controlled clinical trial to study the effect of Rajikushthadi Lepa in Pama
with special reference to scabies in school going 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 Shruti Bhaskar Bhadane |
| Designation |
PG student |
| Affiliation |
SMBT ayurvrd college and hospital |
| Address |
Department of Kaumarbhritya SMBT Ayurved College and hospital Dhamangaon Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
9146865096 |
| Fax |
|
| Email |
drshrutibhadane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Suryawanshi |
| Designation |
Professor |
| Affiliation |
SMBT ayurvrd college and hospital |
| Address |
Department of Kaumarbhritya SMBT Ayurved College and hospital Dhamangaon Nashik,Dist.Nashik,Maharashtra,
India
Nashik
MAHARASHTRA
422403
India |
| Phone |
9420373110 |
| Fax |
|
| Email |
suvisa65@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Bhaskar Bhadane |
| Designation |
PG student |
| Affiliation |
SMBT ayurvrd college and hospital |
| Address |
Department of Kaumarbhritya SMBT Ayurved College and hospital Dhamangaon Nashik
MAHARASHTRA
422403
India |
| Phone |
9146865096 |
| Fax |
|
| Email |
drshrutibhadane@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kaumarbhritya,SMBT Ayurved college and Hospital,Dhamangaon,Nashik
Pin code 422403 Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Shruti Bhaskar Bhadane |
| Address |
Department of Kaumarbhritya SMBT Ayurved College and hospital Dhamangaon Tal.Igatpuri,Dist.Nashik 422403 Maharashtra,India |
| 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 Shruti Bhaskar Bhadane |
SMBT Ayurved College and Hospital |
OPD no 12 Department of Kaumarbhritya SMBT Ayurved College and hospital Dhamangaon Nashik
Nashik
MAHARASHTRA |
09146865096
drshrutibhadane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved College and Hospital |
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: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangddhar samhita uttarkhand 11, Procedure details: Required amount of churna in Mulakbijadi lep is taken & kanji was added in sufficient amount to convert the churna into lep form.Consistency Of lepa should be semisolid -The prepared lepa is applied in pratiloma direction of affected part. - The thickness of lepa will be ¼ angula approx. 0.5 cm - Each application will be kept until it would dry up)))
(1) Medicine Name: Mulakbijadi Lep, Reference: Yogratnakar Hindi commentry by Vd Shri Shastri Kushtha chikitsa verse no 2 page 230, Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Duration: 11 Days | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangddhar samhita uttarkhand 11, Procedure details: Required amount of churna in Rajikushthadi lep is taken and takra was added in sufficient amount to convert the churna into lep form.Consistency Of lepa should be semisolid -The prepared lepa is applied in pratiloma direction of affected part. - The thickness of lepa will be ¼ angula approx. 0.5 cm - Each application will be kept until it would dry up))
(1) Medicine Name: Rajikushthadi lepa, Reference: Chakradatta Balrog chikitsa,Verse 65, Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Duration: 11 Days |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients of school going age group (6 -12 years)
Patients fulfilling the clinical diagnostic criterion for scabies
Selection of patient will be performed irrespective of sex, socio
economic status and community
Parents willing to give consent in written for the treatment |
|
| ExclusionCriteria |
| Details |
Patients of other age group
Pama associated with immunodeficiency disorders such as HIV
Scabies with crust or hyperkeratosis and secondary infection
Known cases of systemic disorders such as diabetes mellitus type 1
Pama associated with any secondary infection. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in signs and symptoms of pama like Kandu(itching),Tod(pain),Dah
(burning sensation),Pitika(Burrows),Strav(discharge) after application of Rajikushthadi lepa |
11 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effect of trial & control drug on following signs & symptoms of pama
Kandu(itching)Toda(Pain)
Pitika(Burrows) Strav(Discharge) Dah(Burning sensation) |
18 month |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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 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
|
According to Indian journal of paediatric dermatology prevalence of scabies in school going children in India is 11 percent. Developing resistance to commonly used drugs like permethrin underscores the need to explore alternative options for local applications.Rajikushthadi lep sounds promising with its kandughna (anti-itch) and kushthaghna (anti-dermatosis) properties, especially considering itching (kandu) is a characteristic feature in (Pama). Addressing itching is crucial in managing various skin conditions including those associated with Pama. Conducting research to evaluate the effectiveness of Rajikushthadi Lepa in treating Pama is crucial for expanding our understanding of traditional remedies and their applications in modern healthcare. By filling the knowledge gap, the study can provide valuable insights into the potential benefits of Rajikushthadi Lepa and its role in managing Pama. Including patients within the school-going age group (6-12 years) who fulfill the clinical diagnostic criteria for scabies, patients are selected irrespective of sex, socio-economic status, and community helps in achieving a diverse and representative sample, enhancing the generalizability of the study findings, written consent from parents ensures ethical compliance and transparency in the treatment process. SAMPLE SIZE using formula by Daniel 1999, the calculated sample size is 37. Simple Random Sampling technique will be used. Total 74 number of patients will be selected and divided into two groups, named as Group A (trial group) and Group B (Control group).Rajikushthadi lepa Group A (trial group) and Mulakbijadi lep Group B(Control group) will be given to patients.Trial and control drugs will be purchased from GMC certified pharmacy. Both drugs will be administered in Lepa form for 11 days. All SOP of Lepa Vidhi will be strictly followed during and after treatment. Observations will be done on day 0, day 3 and day 7. Result of study will drawn on basis of criteria of assessment and statistical analysis.Discussion will be done on the basis of observations and result obtained during the treatment.Summary will be drawn and whole thesis work will be summarized. Conclusion will be drawn strictly on basis of statistical analysis and will be unbiased |