| CTRI Number |
CTRI/2022/05/042417 [Registered on: 09/05/2022] Trial Registered Prospectively |
| Last Modified On: |
30/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A OPEN LABEL CLINICAL COMPARATIVE STUDY OF KARVEER TAIL AND KARVEER CREAM ON KIKKISA WITH SPECIAL REFERENCE TO STRIAE GRAVIDARUM |
|
Scientific Title of Study
|
AN OPEN LABELLED CLINICAL COMPARATIVE STUDY OF KARVEER TAIL AND KARVEER CREAM ON KIKKISA WITH SPECIAL REFERENCE TO STRIAE GRAVIDARUM. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR BHAGYASHREE SURESHRAO HEMKE |
| Designation |
M S SCHOLAR STRI ROGA AND PRASUTI TANTRA |
| Affiliation |
SUMATIBHAI SHAH AYURVED MAHAVIDYALAYA |
| Address |
SUMATIBHAI SHAH AYURVED MAHAVIDYALAYA, MALWADI,HADAPSAR PUNE.
OPD NO 12 ,DEPARTMENT OF PRASUTI AND STRIROGA ,
SANE GURUJI AROGYA KENDRA MALWADI,
HADAPSAR ,PUNE.
Pune
MAHARASHTRA
411028
India |
| Phone |
7972780730 |
| Fax |
|
| Email |
bhagyashreehemke02111995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANDA GHORPADE |
| Designation |
HEAD OF DERPARTMENT OF PRASUTI AND STRIROGA |
| Affiliation |
SUMATIBHAI SHAH AYURVED MAHAVIDYALAYA |
| Address |
SUMATIBHAI SHAH AYURVED MAHAVIDYALAYA,
MALWADI, HADAPSAR ,PUNE.
OPD NO 12 DEPARTMENT OF PRASUTI AND STRIROGA ,
SANE GURUJI AROGYA KENDRA, MALWADI ,HADAPSAR, PUNE
Pune
MAHARASHTRA
411028
India |
| Phone |
9822007570 |
| Fax |
|
| Email |
mandaghorpade@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR BHAGYASHREE SURESHRAO HEMKE |
| Designation |
M S SCHOLAR STRI ROGA AND PRASUTI VIGYAN |
| Affiliation |
SUMATIBHAI SHAH AYURVED MAHAVIDYALAYA |
| Address |
SUMATIBHAI SHAH AYURVED MAHAVIDYALAYA, MALWADI ,HADAPSAR, PUNE.
OPD NO 12 DEPARTMENT OF PRASUTI AND STRIROGA,
SANE GURUJI AROGYA KENDRA, MALWADI, HADAPSAR, PUNE
Pune
MAHARASHTRA
411028
India |
| Phone |
7972780730 |
| Fax |
|
| Email |
bhagyashreehemke02111995@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF PRASUTI AND STRIROGA,
SANE GURUJI AROGYA KENDRA, MALWADI ,HADAPSAR PUNE. 411028 |
|
|
Primary Sponsor
|
| Name |
SANEGURUJI AROGYA KENDRA |
| Address |
SANE GURUJI AROGYA KENDRA, MALWADI, HADAPSAR, PUNE.
411028 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 BHAGYASHREE SURESHRAO HEMKE |
SANE GURUJI AROGYA KENDRA |
OPD NO 12,DEPARTMENT OF PRASUTI AND STRIROGA,
SANE GURUJI AROGYA KENDRA,
MALWADI, HADAPSAR PUNE 411028
Pune
MAHARASHTRA |
7972780730
bhagyashreehemke02111995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: KIKKISA-GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Karveer tail, Reference: charak sharirsthan 8/32, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 120 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Karveer cream, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 120 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
PRIMI GRAVIDA OF 18 TO 30 YEARS OF AGE.
FROM 23RD WEEK UPTO DELIVERY. |
|
| ExclusionCriteria |
| Details |
MULTI PARA.
SKIN DISEASE.
POLY HYDROMNIOS. |
|
|
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 |
| TO STUDY THE EFFECT OF KARVEER CREAM AND KARVEER TAIL ON KIKKISA WITH SPECIAL REFERENCE TO STRIAE GRAVIDARUM |
TREATMENT WILL BE GIVEN FOR 120DAYS.
PATIENT WILL BE ASSESSED ON 0,15,30,60,90 AND 120TH DAY. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| LITERATURE STUDY OF KIKKISA AND STRAIE GRAVIDRAUM |
STUDY WILL BE DONE USING AYURVEDIC GRANTHAS AND MODERN TEXT |
| TO PREPARE KARVEER CREAM AND KARVEER TAIL |
PREPARATION OF DRUGS WILL BE DONE ACCORDING TO PROCEDURE |
| TO OBSERVE ADVERSE EFFECT IF ANY |
DURING TREATMENT OBSERVATION WILL BE DONE FOR ANY ADVERSE EFFECT ON PATIENTS |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
10/05/2022 |
| 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
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS IS AN OPEN LABELLED CLINICAL COMPARATIVE STUDY OF KARVEER TAIL AND KARVEER CREAM ON KIKKISA.THE PRIMARY OBJECTIVE IS TO STUDY THE EFFICACY OF TWO DIFFERENT TOPICAL APPLICATION CREAM AND TAIL MADE UP OF SAME DRUG THAT IS KARVEER. ONE GROUP OF KIKKISA PATIENTS WILL BE TREATED WITH KARVEER CREAM FOR 120DAYS. OTHER GROUP OF KIKKISA PATIENTS WILL BE TREATED WITH KARVEER TAIL FOR 120DAYS. OBSERVATION WILL BE DRAWN FROM THE OUTCOME OF PATIENTS |