| CTRI Number |
CTRI/2025/02/079924 [Registered on: 04/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| 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
|
Efficacy Of Karvir Tail And Kikkisahar Lepa In The Management Of Kikkisa Or Striae Gravidarum |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Karvir Tail And Kikkisahar Lepa In The Management Of Kikkisa W.S.R To Striae Gravidarum |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akriti Ranjan |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government Ayurvedic College And Hospital |
| Address |
Department Of Prasuti Tantra Evum Stree Roga, Government Ayurvedic College And Hospital, Kadamkuan, Patna
Patna
BIHAR
800003
India |
| Phone |
08789691878 |
| Fax |
|
| Email |
akritiranjan29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabha Kumari |
| Designation |
Associate Professor And Head Of Department |
| Affiliation |
Government Ayurvedic College And Hospital |
| Address |
Department Of Prasuti Tantra Evum Stree Roga, Government Ayurvedic College And Hospital, Kadamkuan, Patna
Patna
BIHAR
800003
India |
| Phone |
7004860634 |
| Fax |
|
| Email |
dr.prabhapandey@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Akriti Ranjan |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government Ayurvedic College And Hospital |
| Address |
Department Of Prasuti Tantra Evum Stree Roga, Government Ayurvedic College And Hospital, Kadamkuan, Patna
Patna
BIHAR
800003
India |
| Phone |
8789691878 |
| Fax |
|
| Email |
akritiranjan29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College And Hospital,Kadamkuan,Patna,800003 |
|
|
Primary Sponsor
|
| Name |
Ayurveda College Health Department Government Of Bihar |
| Address |
Government Ayurvedic College And Hospital, Kadamkuan,Patna,800003 |
| Type of Sponsor |
Government medical 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 Prabha kumari |
Government Ayurvedic College And Hospital, Patna |
Department Of Prasuti Tantra Evum Stree Roga, Room no. 1 Government Ayurvedic College And Hospital, Kadamkuan, Patna 800003
Patna
BIHAR |
7004860634
dr.prabhapandey@yahoo.in |
|
|
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:O94-O9A||Other obstetric conditions, not elsewhere classified. Ayurveda Condition: KIKKISA-GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Karvir Tail, Reference: Charak Samhita Sharir Sthan Jatisutriyan Shareeram 8/32., Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: Route-Topical on area of abdomen, thigh & breast | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kikkisahar Lepa, Reference: Charak Samhita Sharir Sthan Jatisutriyan Shareeram 8/32., Route: Topical, Dosage Form: Lepa Churna, Dose: 15(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -Route-Topical on area of abdomen, thigh & breast |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patients will be selected randomly for the study.
Period of pregnancy from 28 th weeks onwards.
Patients having classical signs & symptoms of kikkisa.
Selection of the patients will be irrespective of the gravida. |
|
| ExclusionCriteria |
| Details |
Patients below 18 yrs & above 35 yrs.
Patients having skin diseases other than kikkisa.
Patients having chronic diseases eg. Tuberculosis, jaundice, heart diseases etc. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| determination of effect of the intervention |
8weeks(about 2months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| determination of effect of the intervention with respect to other |
8weeks(about 2months) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
14/02/2025 |
| 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="0"
Months="2"
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
|
There are so many drugs against several health issues, are indicated in Ayurveda one such example is mentioned in Charak Samhita in Sharir Sthan Jatisutriyan Shareeram where a number of medicines are described among them due the easily formulation and great application of Karvira tail and kikkisahar lepa our department (dept. of Prasuti Tantra Evum Stree Roga, Govt. Ayurvedic College, Patna) have decide that there must be a work has needed on this, so that it can be used as in general practice against the health issues for which it has been indicated in ayurveda. That is why this work "A Clinical Study To Evaluate The Efficacy Of Karvir Tail And Kikkisahar Lepa In The Management Of Kikkisa W.S.R To Striae Gravidarum" has been proposed. |