| CTRI Number |
CTRI/2025/09/095294 [Registered on: 23/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [LOCAL APPLCATON] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on the effectiveness of Karviradya Yoga in oil and lotion form for treating stretch marks in first-time mothers |
|
Scientific Title of Study
|
Comparative pharmaceutico-clinical study of Karviradya Yoga for its altered form of
tail and lotion for its efficacy on Kikwis in primi gravida |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashok Rajaram Vankalas |
| Designation |
Post Graduate Scholar |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya and Hosptal |
| Address |
Shree Saptashrungi Ayurved Mahavidyalaya and Hosptal Kamal nagar Hirawadi Panchavati Nashik Maharashtra 422003
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamal nagar Hirawadi Panchavati Nashik Maharashtra 422003 Ground Floor Department of Rasa Shastra and Bhaishajya Kalpana
Nashik
MAHARASHTRA
422003
India |
| Phone |
8237503506 |
| Fax |
|
| Email |
ashokvankalas04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ketki Prakash Adhav |
| Designation |
Associate professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya and Hosptal |
| Address |
Shree Saptashrungi Ayurved Mahavidyalaya and Hosptal Kamal nagar Hirawadi Panchavati Nashik Maharashtra 422003
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamal nagar Hirawadi Panchavati Nashik Maharashtra 422003 Ground Floor Department of Rasa Shastra and Bhaishajya Kalpana
Nashik
MAHARASHTRA
422003
India |
| Phone |
8237803992 |
| Fax |
|
| Email |
ketakiadhav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ketki Prakash Adhav |
| Designation |
Associate professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya and Hosptal |
| Address |
Shree Saptashrungi Ayurved Mahavidyalaya and Hosptal Kamal nagar Hirawadi Panchavati Nashik Maharashtra 422003
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamal nagar Hirawadi Panchavati Nashik Maharashtra 422003 Ground Floor Department of Rasa Shastra and Bhaishajya Kalpana
Nashik
MAHARASHTRA
422003
India |
| Phone |
8237803992 |
| Fax |
|
| Email |
ketakiadhav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamal nagar Hirawadi Panchavati Nashik Maharashtra 422003 |
|
|
Primary Sponsor
|
| Name |
Dr Ashok Rajaram Vankalas |
| Address |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamal nagar Hirawadi Panchavati Nashik Maharashtra 422003 |
| 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 Ashok Rajaram Vankalas |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital |
OPD NO. 4 Ground Floor Streeroga and Prasuti Tantra Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamal nagar Hirawadi Panchavati Nashik Maharashtra 422003
Nashik
MAHARASHTRA |
8237503506
ashokvankalas04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Shree Saptashrungi Ayurved Mahavidyalaya, Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O997||Diseases of the skin and subcutaneous tissue complicating pregnancy, childbirth and the puerperium. Ayurveda Condition: KIKKISA-GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: Karviradya Lotion, Procedure details: Local application of Karviradya Lotion of 10ml Every day before going to bed (before sleep) ))
(1) Medicine Name: Karviradya Lotion, Reference: As. Hr. Sh. 1/58, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(ml), Frequency: od, Duration: 84 Days | | 2 | Intervention Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: As. Hr. Sh. 1/58, Procedure details: Local application of Karviradya Tailam of 10ml Every day before going to bed (before sleep) )
(1) Medicine Name: Karviradya yoga, Reference: As. Hr. Sh. 1/58, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(ml), Frequency: od, Duration: 84 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Primigravida women.
Singleton pregnancy
20-22weeks of Gestational age at time of recruitment.
Absence of abdominal striae.
Age more than 21 years at recruitment. |
|
| ExclusionCriteria |
| Details |
Multigravid women.
Preterm delivery.
Women who decline to discontinue other creams and lotion.
Women who unable to give consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To prepare Karviradya Tailam and Karviradya lotion by standard operating
procedure.
To observe the efficacy of tail form on kikwis in primi gravida.
To observe the efficacy of lotion form on kikwis in primi gravida. |
0 day assessment onset
1 st follow up on 28th day
2 nd follow up on 56th day
3 rd follow up on 84th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe the efficacy of tail form on kikwis in primi gravida.
To observe the efficacy of lotion form on kikwis in primi gravida. |
0 day assessment onset
1 st follow up on 28th day
2 nd follow up on 56th day
3 rd follow up on 84th day |
|
|
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 |
|
Date of First Enrollment (India)
|
01/11/2025 |
| 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 holistic system and science of life, which is practiced by many
Vaidya. Ayurveda emphasize both prevention and treatment of disease. It offers
numerous medicinal products with beautification properties, making them suitable
for cosmetic use.
Rasa Shastra and Bhaishajya Kalpna is crucial branch of Ayurveda that encompasses
the study of medicines preparation, consumption methods, application and shelf life.
The natural form of any medicine is often not practice for treatment, requiring
modification through Kalpana. The branch of Ayurveda responsible for preparation
and modifying medicine is called Bhaishajya Kalpana. It provide broad understanding
of internal and external application of medicines such as Guti,Vati, Lepa, Avaleha,
Sneha, Anjana, Malahara, Sandhana.
A women is considered the embodiment of beauty created by Divine. Women plays
a sacrade role in creation, nurturing and sustainance of life within the womb.
Experiencing motherhood is a profound joy for every women, who anticipates a
fruitful pregnancy and delivery. Therefore, it’s crucial to enhance the physical and
mental health well-being of expectant mother. To achieve this our ancient scholar,
have out lined guidelines know as ’Garbhini Paricharya’. Aacharya Vaghabhat, in
particular has provided detailed insight into ’Garbhini Kikwis’1 and their management.
Garbhini Kikwis, also known as Striae gravidarum are stretch marks that commonly
appear during pregnancy, typically in the second trimester. They manifest with
symptoms such as itching (Kandu), burning sensation (Daha) and discoloration
(Vaivarnya). These marks are often observed particularly on the abdomen, breast
region and thighs. Women are often very concern about their appearance and
beauty, stretch marks can affect their self-confidence as they perceive them as
making their appearance less attractive. Stretch marks appear as visible linear, pinkish
scar that develop in areas where dermis has been damage due to excessive stretching
of skin and weakening of elastic tissue.In the present era, there is a wide range of skin care products and innovative
procedures available, including laser surgeries and dermabrasion. However, there is
no promising treatment for striae gravidarum available in market, and this existing
treatment can be expensive and invasive. Therefore, people are increasingly turning
to Ayurveda in search of safer and more effective methods to address these
troublesome stretch marks during pregnancy.
Currently, there is no specific Ayurvedic lotion proven to be highly effective in
eradication or improving stretch marks. The management of Kikwis is outlined in
various ancient ayurvedic texts such as, Charak Samhita, Ashthang Hridya, Ashthang
Sangrah and Bhel Samhita. Ayurveda recommend treatment like Aaushadhi sevana,
Parisheka, Abhayanga, Lepa and Pathyapathya to alleviate the severity of Kikwis.
Indeed, people are increasingly drawn to the convenience of topical application, such
as Lotions, for their ease of use anytime and anywhere. Additionally, lotions are often
cost effective and provide users with sense of mental satisfaction after application.
NEED OF THE STUDY
1. Currently there are less number of lotion formulated from Ayurvedic medicine
specifically designed for Kikwis.
2.To enhance the absorption through the skin and alleviate the unpleasant odor
associate with Sneha Kalpana prepared medicines, exploring modification is crucial.
3. Evaluating the efficacy of their modification is essential for various external
application across numerous disorders.
4. The study aims to prepare Karviradya yoga and explore its modification into tail
and lotion form.
5. Both formulations will undergo evaluation and comparison for their effect on
Kikwis to find better option between them.
6.Lotion formulation offer ease of use and application for patients and providing a
convenient option that save time. |