| CTRI Number |
CTRI/2025/04/084511 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pregnancy stretch marks will be reduced by ingidineous drugs |
|
Scientific Title of Study
|
An Open Labelled Randomised Controlled Clinical Study To
Evaluate The Effect Of Extrernal Application Of Daruharidra
And Madhuka Ointment In Kikkisa W.S.R To Straie 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 |
Neha shetty |
| Designation |
PG scholar |
| Affiliation |
S D M College of Ayurveda,Kuthpady |
| Address |
SDM college of ayurveda and hospital, kuthpady, udupi Benaka nilaya,near bharath petrol,Thekkatte, kundapura, udupi Udupi KARNATAKA 574118 India |
| Phone |
9902399369 |
| Fax |
|
| Email |
Nehashetty763@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Arpana |
| Designation |
Asst. Professor of Prasooti Tantra & Stree Roga |
| Affiliation |
S D M College of Ayurveda,Kuthpady |
| Address |
S D M College of Ayurveda,Kuthpady,Udupi, Karnataka,India
Udupi KARNATAKA 574118 India |
| Phone |
919880288577 |
| Fax |
|
| Email |
Arpanajainsdm@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Arpana |
| Designation |
Asst. Professor of Prasooti Tantra & Stree Roga |
| Affiliation |
S D M College of Ayurveda,Kuthpady |
| Address |
S D M College of Ayurveda,Kuthpady,Udupi, Karnataka,India
KARNATAKA 574118 India |
| Phone |
919880288577 |
| Fax |
|
| Email |
Arpanajainsdm@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM COLLEGE OF AYURVEDA AND HOSPITAL KUTHPADY UDUPI KARNATAKA INDIA 574118 |
|
|
Primary Sponsor
|
| Name |
Dr Neha shetty |
| Address |
S D M College of Ayurveda,Kuthpady,Udupi,Karnataka, India, 574118 |
| Type of Sponsor |
Private 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 Neha |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research centre |
department of prasooti tantra and stree roga room number 1 Udupi KARNATAKA |
9902399369
nehashetty763@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical clearance commitee- human Sri Dharmasthala Manjunatheshwara College of Ayurveda and hospital Kuthpady Udupi Karnataka India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L988||Other specified disorders of the skin and subcutaneous tissue. Ayurveda Condition: KIKKISA-GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Daruharidra and yashtimadhu, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patients with straie over lower abdomen,thighs and breasts
Primigravida in her 3d trimester
Age group of 18-35 years |
|
| ExclusionCriteria |
| Details |
Hydramnios and multiple pregnancy, pregnancy with ovarian cyst or huge fibroid.
All systemic diseases like diabetes mellitus, hypertension, tuberculosis etc
Skin disease due to other causes. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Daruharidra and madhuka ointment in kikkisa. |
8weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Daruharidra and madhuka ointment in kikkisa. |
Follow up -once in 15Days |
|
|
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 |
|
Date of First Enrollment (India)
|
01/06/2025 |
| 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="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Pregnancy is a phase of women’s life during the period of 9 months she undergoes major changes both physically and psychologically Acharyas have mentioned to protect the Garbhini without vitiating the doshas just like how carefully a vessel filled with oil will be taken care of to avoid spillage This shows the importance of care and concern which must be given to every pregnant woman However it is associated with many physiological changes on body and skin, one among them being kikkisa i.e. which produce Rekhaswaroopa Tvak Sankocha [linear lesions] commonly found on the Udara Stana and Uru during 3rd trimester Due to stretching of the abdominal muscles are characterized by Kandu(itching) Vidaha (burning sensation) Based on the similarity of features it can be correlated to Striae Gravidarum in contemporary science. When the fetus grows uterus enlarges causes mechanical stretching of the abdominal skin leading to linear marks on the skin. Even the slightest Scar can cause psychological stress in her as it impacts on the beauty, and no women is ignorant about her beauty as it reflects the confidence and personality. Any measure which helps in this condition will be a boon for the women.Almost 90% of Garbini face this problem worldwide though kikkisa is not a disease at times seeks a lot of attention there is very need for cosmetic medicine to overcome this problenm In Astangha Hridaya shareerasthana while explaining about kikkisa chikitsa explains about Daruharidra and Madhuka which are kandughna krimiglma raktashodhaka shothahura vayastapana dahashamaka. Present era working pregnant women daruharidra and madhuka ointment helps in easy effective application hence the combination is taken up for the study. |