| CTRI Number |
CTRI/2025/01/079808 [Registered on: 30/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [curative] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study of modified cream form of
Sahachara Ghrita on Acne. |
|
Scientific Title of Study
|
Pharmaceutico-Analytical study and clinical evaluation of modified cream form of
Sahachara Ghrita on Mukhdushika with special reference to Acne vulgaris:A
Randomized Controlled Trial |
| 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 Manjusha Suresh Uikey |
| Designation |
PG Scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya, Nagpur |
| Address |
Rasashastra and Bhaishajyakalpana Department,
Pakwasa Samanvay Rugnalaya,
Shri Ayurved Mahavidyalaya,
Hanuman Nagar, Nagpur 440024,
Maharashtra, India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
8275549239 |
| Fax |
|
| Email |
manjushauikey75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Ramteke |
| Designation |
Associate Professor |
| Affiliation |
Shri Ayurved Mahavidyalaya, Nagpur |
| Address |
Rasashastra and Bhaishajyakalpana Department,
Pakwasa Samanvay Rugnalaya,
Shri Ayurved Mahavidyalaya,
Hanuman Nagar, Nagpur 440024,
Maharashtra, India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9423414191 |
| Fax |
|
| Email |
vinodramteke1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinod Ramteke |
| Designation |
Associate Professor |
| Affiliation |
Shri Ayurved Mahavidyalaya, Nagpur |
| Address |
Rasashastra and Bhaishajyakalpana Department,
Pakwasa Samanvay Rugnalaya,
Shri Ayurved Mahavidyalaya,
Hanuman Nagar, Nagpur 440024,
Maharashtra, India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9423414191 |
| Fax |
|
| Email |
vinodramteke1970@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rasashastra and Bhaishajyakalpana Department,
Pakwasa Samanvay Rugnalaya,
Shri Ayurved Mahavidyalaya,
Hanuman Nagar, Nagpur
Maharashtra,
Pin code - 440024,
 India |
|
|
Primary Sponsor
|
| Name |
Dr Manjusha Suresh Uikey |
| Address |
Rasashastra and Bhaishajyakalpana Department,
Pakwasa Samanvay Rugnalaya,
Shri Ayurved Mahavidyalaya,
Hanuman Nagar, Nagpur 440024,
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 Manjusha Suresh Uikey |
Shri Ayurved Mahavidyalaya, Nagpur |
Rasashastra and Bhaishajyakalpana Department,
Pakwasa Samanvay Rugnalaya,
Shri Ayurved Mahavidyalaya,
Hanuman Nagar, Nagpur 440024,
Maharashtra, India
Nagpur
MAHARASHTRA |
08275549239
manjushauikey75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Ayurved Mahavidyalaya, Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L988||Other specified disorders of the skin and subcutaneous tissue. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA), (2) ICD-10 Condition:L988||Other specified disorders of the skin and subcutaneous tissue. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shalmali Kanatak Lepa, Reference: Yogratnakara Uttarardha Nidan Kshudraroga 44/5, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Shalmali Kanatak powder mix with milk for topical application. | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Modified cream form of Sahachara Ghrita, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Sahachara Ghrita mentioned in Bhaishajyaratnavali for Mukhadushika |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patient having symptom of Mukhadushika -
1)Shalmali Kantak like eruptions
2)Saruja pidika(painful acne)
3)Ghana Pidikas (hard and thick acne)
4)Medogarbha Pidikas (acne filled with oil/sebum/pus)
5)Shotha (Inflammation)
6) Patient having symptom of acne vulgaris
7) Open comedones (White head)
8)Close comedones (black heads)
9) Papule
10)Pustule.
11)Nodules |
|
| ExclusionCriteria |
| Details |
1)Patient suffering from any other skin disease and any allergic condition.
2)Patients of severe acne having inflammatory cyst.
3)Patients having hormonal imbalance like PCOD etc.
4)Genetic disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prepare Sahachara Ghrita and its cream form, to study its organoleptic, physio-chemical, phyto-chemical parameters and clinically compare its effect with Shalmali Kantaka Lepa on Mukhadushika. |
Follow up 0th,15th,30th,and 45th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/02/2025 |
| 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="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
|
In the present study, total 60 participants will be taken for trial dividing them in 2 equal groups. Grp-A will receive the trial drug Modified cream form of Sahachara Ghrita and Grp-B will receive the controlled drug Shalmali Kantaka Lepa for external application for 30 days. Follow up will be taken on Day-0th,15th,30th,45th. Result will be concluded based on assessment criteria. |