| CTRI Number |
CTRI/2023/10/058304 [Registered on: 05/10/2023] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Preparation of soap and cream with medicated Trinak oil and its clinical trial in skin disease. |
|
Scientific Title of Study
|
Development, Pharmaceutical, Analytical study of soap and cream prepared with Trinak Taila as main ingredient and its clinical study in Dadru Kustha Roga |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Seema |
| Designation |
PG Scholar |
| Affiliation |
Shri Krishna Govt Ayurvedic College and Hospital |
| Address |
Room number 37 PG Department of Rasa Shastra and Bhaisajya Kalpana Shri Krishna Govt Ayurvedic College and Hospital, Umri Road sector 8
Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
7973299267 |
| Fax |
|
| Email |
seemagahlyan24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ravi Raj |
| Designation |
Associate Professor |
| Affiliation |
Shri Krishna Govt Ayurvedic College and Hospital |
| Address |
Room number 37 PG Department of Rasa Shastra and Bhaisajya Kalpana Shri Krishna Govt Ayurvedic College and Hospital, Umri Road sector 8
Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
7988499972 |
| Fax |
|
| Email |
raviraz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Seema |
| Designation |
PG Scholar |
| Affiliation |
Shri Krishna Govt Ayurvedic College and Hospital |
| Address |
Room number 37 PG Department of Rasa Shastra and Bhaisajya Kalpana Shri Krishna Govt Ayurvedic College and Hospital, Umri Road sector 8
Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
7973299267 |
| Fax |
|
| Email |
seemagahlyan24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Krishna Govt Ayurvedic College and Hospital Kurukshetra, Haryana 136118 |
|
|
Primary Sponsor
|
| Name |
Shri Krishna Govt Ayurvedic College and Hospital |
| Address |
Shri Krishna Govt Ayurvedic College Umri road sector 8 Kurukshetra Haryana 136118 |
| 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 |
| Seema |
Shri Krishna Govt Ayurvedic College and Hospital |
Room no 37, PG Department of Rasa Shastra and Bhaisajya Kalpana Shri Krishna Govt Ayurvedic College and Hospital, umri road sector 8
Kurukshetra 136118
Haryana
Kurukshetra
HARYANA |
7973299267
seemagahlyan24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trinak Taila, Reference: Chakaradutta, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Trinak Tail ointment, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with the signs and symptoms of Dadru Kushtha described in Ayurvedic texts will be selected |
|
| ExclusionCriteria |
| Details |
Patients on auto immune suppressants, patients having medical history of unstable angina, myocardial infarction, heart failure or stroke within 3 months of study, uncontrolled DM, Impaired renal function ALT and AST>2 times of upper limit of normal, patients on prolonged steroid therapy and age less than 18 yrs and more than 65 yrs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To develop & evaluate pharmaceutical, analytical study of Soap and Cream prepared with Trinak Taila and its clinical study in Dadru Kustha Roga within one year. |
Duration of the treatment- 28 days
follow up- done after 14 days, 28 days and 45 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study pharmaceutical analytical evaluation of soap prepared from Trinak Tail.
2.To study pharmaceutical analytical evaluation of cream prepared from Trinak Tail.
3.To trace out clinical efficacy of soap in Dadru Kustha Roga.
4.To trace out clinical efficacy of soap & cream in Dadru Kustha Roga.
the whole procedure will be completed within 1 yr . |
Duration of the treatment- It will be given for 30-60 days.
Route of administration- Local application
Dose- According to skin lesion
Follow up- Follow up will be done fortnightly for 45 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
03/11/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
first patient enrolled on 27/02/24 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All the skin diseases in Ayurveda have been classified in to Mahakustha and Kshudra Kustha. Dadru is one among the Kustha. Acharya Charak has included Dadru in Kshudra Kustha where as Acharya Sushruta and Acharya Vagbhata have explained under Mahakustha. It involves the clinical features like Kandu, Raga, Pidika, Mandala, Utsanna which exhibits the involvement of Kapha and Pitta dosha. In the explanation of chikitsa for Dadru, Bahhiparimarjan chikitsa is mentioned. Therefore the Trinak Taila mentioned in the Chakradutta which reduces the symptoms of Dadru is taken for study. All patients will be selected from OPD of Shri Krishna Govt Ayurvedic College and Hospital, Kurukshetra. Patients with age group between 18-65 yrs with lakshan of dadru will be selected. Patients below 18yrs and above 65 yrs of age along with long standing medicine, chronicity more than 2 yrs and associated with other skin diseases will be excluded. Maximum 20 patients are in two groups. Group A has 10 patients advised for local application of Trinak Taila and Group B has 10 patients advised for local application of ointment prepared with Trinak Taila. Follow up will be done after every 7 days during trial. After completing trial for 30 days, patients will be reassessed again every 15 days for 45 days to assess the efficacy of trial drug. |