FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091208 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 18/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of Nimbadi taila and Karveer patra siddha taila for local application in the management of Striae gravidarum in pregnancy patients  
Scientific Title of Study   Randomized controlled clinical trial to evaluate the efficacy of Nimbadi taila in the management of garbhini kikkwis (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 Shubhangi Balajirao Kshirsagar  
Designation  PG Scholar  
Affiliation  CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad Maharashtra  
Address  OPD No 19 Prasutitantra And Streeroga Department CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011

Aurangabad
MAHARASHTRA
431011
India 
Phone  8999722566  
Fax    
Email  shubhangiksagar554@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amol Havale 
Designation  Associate professor  
Affiliation  CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad 
Address  OPD NO 19 Prasutitantra And Streeroga Department CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad

Aurangabad
MAHARASHTRA
431011
India 
Phone  9822538957  
Fax    
Email  amolhavale@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shubhangi Balajirao Kshirsagar 
Designation  PG Scholar  
Affiliation  CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad 
Address  OPD NO 19 Prasutitantra And Streeroga Department CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad

Aurangabad
MAHARASHTRA
431011
India 
Phone  8999722566  
Fax    
Email  shubhangiksagar554@gmail.com  
 
Source of Monetary or Material Support  
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 
 
Primary Sponsor  
Name  CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 
Address  CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 
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 Shubhangi Balajirao Kshirsagar  CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India   OPD NO 19 Prasutitantra And Streeroga Department CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India
Aurangabad
MAHARASHTRA 
08999722566

shubhangiksagar554@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L819||Disorder of pigmentation, unspecified. Ayurveda Condition: KIKKISA-GARBINIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Nimbadi taila , Reference: Charak sharirsthan 8/32 , Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Karveer patra siddha taila , Reference: Charak sharirsthan 8/32 , Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  7.00 Month(s)
Age To  9.00 Month(s)
Gender  Female 
Details  1. Patients willingly participating in the trial and giving
Consent form.
2. Patients with gestational age of 28 weeks onward upto
Delivery.
3. Patients having classical sign and symptoms of Kikkwis
as per prepared Performa will be selected.
4. Primi gravida patients will be selected for study.  
 
ExclusionCriteria 
Details  1. Patients not willing to participate in the trial.
2. Patients having Skin disease will be excluded.
3. Any malignancy on affected part will be excluded.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Classical signs and symptoms of Striae Gravidarum decreses  Baseline-15th,30th,45th,60th 
 
Secondary Outcome  
Outcome  TimePoints 
Discoloration of Striae   2 months 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   05/08/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Ayurveda is a science of life , which gives importance to both preventive and curative aspects of disease , enriched with various medicinal herbs for the management of different
disorders by external and internal use.
 Pregnancy is a very beautiful time in a women’s life. Duringpregnancy there are profound anatomical and physiological changes to adopt and support the entire period of 9 months of
pregnancy.
 Kikkwis is a clinical entity which appears in the 7th month of pregnancy , characterized by Kandu (itching) , Vidaha (burning sensation) and Rekhaswaroopa Twak Vidaran ( linear Striae)
found on the Udara (Abdomen) , Stana ( Breast) and Uru (Thigh) region due to growing foetus and stretching of abdominal skin.
 It can be correlated to Striae Gravidarum in contempory science 
 Garbhini Kikkwis has been described in Charak Samhita , Ashtang Sangrah , Ashtang Hrudaya and Bhel Samhita .
 According to Charak, due to growth of scalp hairs of the foetus in the seven month.
The mother get vidaha ( burning sensation) resulting into development of Kikkwis. However,
Atreya says, no it’s not so the growing foetus displaces the Doshas upward reaching
Uras(chest) produces Vidaha and Kandu 
 Aacharya vagbhat follows the concept of Charak but states that Doshas resides in
Hridaya (Heart) causes itching and burning. 
Chakrapani opinions that growth of hair can not be the cause as these start developing from third month itself.
 Arundatta  has included burning sensation of palm and sole also as a symptom.
 The vitiated pitta is seen to produce its effect first causing vidhah and subsequently kandu which is due to vitiation of Kapha. These two doshas when they vitiate Vaata to a greater extent and then produce vidaran of the Twak.
 According to modern science, Striae Gravidarum usually occurs during second trimester of pregnancy. Seven month onward the uterus enlarged due to growing foetus and produces stretching of abdominal skin, due to this stretching linear lines appear over the skin of abdomen, breast and thighs .
 Initially Striae Gravidarum are pinkish but after delivery the scar tissues contract and obliterate the capillaries and they become glistening white in appearance. These stretch marks represents the scar tissues in the deeper layers of cutis.
 Antenatal itching leads to irritability and disturbance of pregnant women’s body and mind while postnatal persistence of permanent stretch marks also cause crude appearance,
depriving her of confidence and looks.
 In modern science; this condition is treated with antihistaminic drugs and steroids for its symptomatic relief and second option is surgery i.e. abdominoplasty and laser surgery. This line of treatment not only expensive but also having many side effects. Hence, there is a need for herbal medicines for the management of Garbhini Kikkwis which is cost effective and with less side effects.
 
Close