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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther 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. 
 
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