| CTRI Number |
CTRI/2025/07/091565 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
27/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of karanj taila abd abhaya taila in striae to know the outcome of the both taila |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of karanj taila and abhaya taila in the management of garbhini kikkis wsr 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 |
Dr Sufiya Bee Msnsoori |
| Designation |
Post Graduate resident |
| Affiliation |
Jeevan jyoti ayurvedic medical college and hospital |
| Address |
Department of prasuti Tantra evum stree roga
PG Second floor Room Number 203
Jeevan jyoti ayurvedic medical college and hospital
Jeevan Jyoti Ayurvedic medical college and hospital
Aligarh
UTTAR PRADESH
202140
India |
| Phone |
7999855842 |
| Fax |
05712213536 |
| Email |
sufiya.mansuri1786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Mamata kumari swain |
| Designation |
MD PhD in prasuti Tantra evum stree roga |
| Affiliation |
Jeevan jyoti ayurvedic medical college and hospital |
| Address |
Department of Prasuti tantra evum stree roga
PG Second floor Room number 203
jeevan jyoti ayurvedic medical college and hospital
Jeevan jyoti ayurvedic medical college and hospital
Aligarh
UTTAR PRADESH
202140
India |
| Phone |
9348576189 |
| Fax |
05712213536 |
| Email |
swaindrmamata@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Mamata kumari swain |
| Designation |
MD PhD in prasuti Tantra evum stree roga |
| Affiliation |
Jeevan jyoti ayurvedic medical college and hospital |
| Address |
Department of prasuti tantra evum stree roga
PG second floor Room number 203
Jeevan jyoti ayurvedic medical college and hospital
10th km mile stone khair road lodha aligarh
Aligarh
UTTAR PRADESH
202140
India |
| Phone |
9348576189 |
| Fax |
05712213536 |
| Email |
swaindrmamata@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jeevan jyoti ayurvedic medical college and hospital
10 th km mile stone khair road lodha aligarh uttar pradesh 202140
india
|
|
|
Primary Sponsor
|
| Name |
Dr Sufiya Bee Mansoori |
| Address |
Jeevan jyoti ayurvedic medical college and hospital
10th kM mile stone khair road lodha aligarh uttar pradesh india 202140 |
| 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 Sufiya Bee Mansoori |
Jeevan jyoti ayurvedic medical college and hospital |
10TH KM mile stone khair road lodha aligarh
Aligarh
UTTAR PRADESH |
7999855842
05712213536
sufiya.mansuri1786@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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:O268||Other specified pregnancy relatedconditions. Ayurveda Condition: KIKKISA-GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Abhyanga | (Procedure Reference: Dravya guna prakashika on Raj nighantu of Pandit narhari kshiradi varga chapter 15 verse 121, Procedure details: Local application of taila twice a day)
(1) Medicine Name: Abhaya taila, Reference: Dravya guna prakashika on Raj nighantu of Pandit narhari kshiradi varga chapter 15 verse 121, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Duration: 3 Months | | 2 | Intervention Arm | Procedure | - | Abhyanga | (Procedure Reference: Indu tika of ashtang samgraha chapter 3 verse 8, Procedure details: local application of taila twice a day)
(1) Medicine Name: Karanj taila, Reference: indu tika of ashtang samgraha chapter 3 verse 8, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Duration: 3 Months |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Period of pregnancy from 6th month onwards
Primi and multi gravida
Post delivery patients
No occurrence or mild occurrence of sign and symptoms of kikkis |
|
| ExclusionCriteria |
| Details |
Below 20 years and above 40 years of age group
Any type of skin diseases other than kikkis
Patients having any systemic disease |
|
|
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 compare the clincal efficacy of abhaya taila and karanj taila |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate the effect of abhaya taila in kikkis |
3 months |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/08/2025 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In the present study we will first observe and discuss the efficacy of karanj taila and abhaya taila separately in the management of garbhini kikkis and then compare the end result of both the tailas.The study design also include conceptual , drug and disease review, clinical study , mode of action and various criteria. Based on this study we will discuss the conclusion of both the drug and compare their effect simultaneously. |