| CTRI Number |
CTRI/2023/03/050598 [Registered on: 13/03/2023] Trial Registered Prospectively |
| Last Modified On: |
12/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative clinical study to check the effect of laghumanjishthadi Kwatha and Aatrushadi kwatha in the treatment of Dadru kushtha. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of laghumanjishthadi Kwatha and Aatrushadi kwatha in the management of Dadru kushtha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nikita Wakchaure |
| Designation |
PG Scholar |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidhyalay |
| Address |
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 ,shukrawar peth,near juni faujdar chawdi, solapur
Madhavsmriti near Old Dattamandir, Dattachowk, Solapur
413007
Solapur
MAHARASHTRA
413002
India |
| Phone |
9284744762 |
| Fax |
|
| Email |
nikita.wakchaure@pg.sgrayurved.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Chandurkar |
| Designation |
HOD Kayachikitsa Department |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidhyalay |
| Address |
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 ,shukrawar peth,near juni faujdar chawdi, solapur
Madhavsmriti near Old Dattamandir, Dattachowk, Solapur
413007
Solapur
MAHARASHTRA
413002
India |
| Phone |
9422788569 |
| Fax |
|
| Email |
vivek.chandurkar@sgrayurved.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikita Wakchaure |
| Designation |
PG Scholar |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidhyalay |
| Address |
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 ,shukrawar peth,near juni faujdar chawdi, solapur
Madhavsmriti near Old Dattamandir, Dattachowk, Solapur
413007
Solapur
MAHARASHTRA
413002
India |
| Phone |
9284744762 |
| Fax |
|
| Email |
nikita.wakchaure@pg.sgrayurved.edu.in |
|
|
Source of Monetary or Material Support
|
| Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth,near juni faujdar chawdi, solapur |
|
|
Primary Sponsor
|
| Name |
Dr Nikita Wakchaure |
| Address |
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth,near juni faujdar chawdi, solapur |
| Type of Sponsor |
Other [Gov Grant In Aid Ayurved College] |
|
|
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 Nikita Wakchaure |
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya |
OPD No 2,3 Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth,near juni faujdar chawdi, solapur
Solapur
MAHARASHTRA |
9284744762
nikita.wakchaure@pg.sgrayurved.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS |
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: DADRU-KUSHTHAH, (2) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Laghumanjishthadi kwatha, Reference: Bhavaprakash madhyam khand 54, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Aatrushadi Kwatha, Reference: Bhaishajyaratnavali (Kushtharogadhikar 71), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects with classical sign & symptoms of Dadru i.e. Kandu, Pidikotpatti, Raga, Utsanna
mandala.
2) Subjects of either gender and age group between 20-60 years irrespective of religion,
occupation and socio-economic status will be selected.
3) Subjects having symptoms of dadru kushtha within the time period of 6 month. |
|
| ExclusionCriteria |
| Details |
1) Subjects of Dadru with any secondary complication.
2) Subjects who are suffering from any other type of skin disease like Herpes zoster, eczema.
3) Subjects who are suffering from any other known case of systemic Diseases i.e.
Uncontrolled DM etc.
3) Pregnant and lactating women.
4) Subjects taking immunosuppressive medications. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare the efficacy of Laghumanjishthadi kwatha and Aatrushadi kwatha in the management of Dadru Kushtha in time period of 45 days |
45 Days with follow up on 15th,30th,45th Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1)To analyse the process of samprapti vighatana of Dadru Kushtha in 45 days. |
45 Days with follow up on 15th,30th,45th Days |
|
|
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)
|
14/03/2023 |
| 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="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Due to changing life style, dietary inconsistencies, environmental factors like high humidity, the incidents of skin disease are increasing day by day. and conventional system fails to find a permanent solution for it. Therefore, whole world is gradually turning towards Ayurveda for safe cure of diseases. Especially in the field of skin problems, Ayurveda can contribute remarkably. Hence sincere efforts are made in order to find potent Ayurvedic treatment for the same. There are some previous combined studies of Bahiparimajan and Antaparimarjan dravyas. But now a days due to busy life schedule sometimes it is not convenient to Subjects to do bahiparimajan chikitsa, so here we will do only Antaparimajan Chikitsa and also the Kwatha which I have choosen for study has comparatively less drugs which are affordable to Subjects in future. |