| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L819||Disorder of pigmentation, unspecified. Ayurveda Condition: KIKKISA-GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Comparator Arm | Drug | Classical | | (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. |