| CTRI Number |
CTRI/2025/02/080145 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of one ayurvedic oil in pregnancy stretchmarks. |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the role of aaragwadha patra taila in garbhini kikwisa w.s.r.to 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 Shital Dnyanoba More |
| Designation |
MS Prasutitantra Evam Streerog Scholar |
| Affiliation |
Matoshree Asarabai Darade Ayurved College Babhulgoan ,Yeola |
| Address |
OPD No.8 Department of Prasutitantra evum Streerog Matoshree Asarabai Darade Ayurved College Babhulgoan Tal- yeola Dist-Nashik Pin-423401 Maharashtra India
Nashik
MAHARASHTRA
423401
India |
| Phone |
9545706791 |
| Fax |
|
| Email |
shitalmore.sm1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin More |
| Designation |
Professor PG Guide Prasutitantra evum Streerog Department |
| Affiliation |
Matoshree Asarabai Darade Ayurved College Babhulgoan ,Yeola |
| Address |
OPD No.8 Department of Prasutitantra evum Streerog Matoshree Asarabai Darade Ayurved College Babhulgoan Tal- yeola Dist-Nashik Pin-423401 Maharashtra India
Nashik
MAHARASHTRA
423401
India |
| Phone |
9822874480 |
| Fax |
|
| Email |
sachinmore070979@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shital Dnyanoba More |
| Designation |
MS Prasutitantra Evam Streerog Scholar |
| Affiliation |
Matoshree Asarabai Darade Ayurved College Babhulgoan ,Yeola |
| Address |
OPD No.8 Department of Prasutitantra evum Streerog Matoshree Asarabai Darade Ayurved College Babhulgoan Tal- yeola Dist-Nashik Pin-423401 Maharashtra India
Nashik
MAHARASHTRA
423401
India |
| Phone |
9545706791 |
| Fax |
|
| Email |
shitalmore.sm1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prasutitantra Evum Streerog Matoshree Asarabai Darade Ayurved College Babhulgaon Tal-Yeola Dist-Nashik Maharashtra PIN-423401 India |
|
|
Primary Sponsor
|
| Name |
Matoshree Asarabai Darade College Babhulgoan Yeola |
| Address |
OPD No.8 Department of Prasutitantra Evum Streerog Matoshree Asarabai Darade Ayurved College Babhulgaon Tal-Yeola Dist-Nashik Maharashtra Pin-423401 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shital Dnyanoba More |
Matoshree Asarabai Darade Ayurved College Babhulgoan , Yeola |
OPD No.8 Department of Prasutitantra evum Streerog
Nashik
MAHARASHTRA |
9545706791
shitalmore.sm1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Matoshree Asarabai Darade Ayurved College Babhulgoan Yeola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L906||Striae atrophicae. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | अभ्यंग | (Procedure Reference: Panchkarma Sangrah by Manoj Shamkuwar , Procedure details: Apply Karveerpatra siddha tail all over abdomen region daily at morning.
Massage using gentle pressure & small circular movements.)
(1) Medicine Name: Karveerpatra siddha tail , Reference: Charak sharir 8, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 4 Months | | 2 | Intervention Arm | Procedure | - | Abhyanga | (Procedure Reference: Panchakarma sangrah by manoj k shamkuwar, Procedure details: Apply all over abdomen region daily at morning
Massage using gentle pressure and circular movement )
(1) Medicine Name: Aaragwadha patra taila, Reference: Vaidya Manorama , Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 4 Months |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
i)Patients willingly participating in the trial and giving consent form.
ii)Primi gravidae patients will be selected for study.
iii) Patients with gestational age of 7
th month onward up to delivery.
Iv) Patients having classical sign and symptoms of
Garbhini kikwisa as per prepared Performa will be
selected. |
|
| ExclusionCriteria |
| Details |
i)Multi-gravida
ii) Diabetic mother.
iii) Patients not willing to participate in the trial.
iv) Any malignancy on the affected part
v) Patients having skin disease
|
|
|
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 |
1.Kandu (Itching)
2.Vidaha (Burning sensation)
3.Vali vishesh (Strech mark)
4.Vaivarnyata (Discolouration)
all symptoms will be decreased |
First day,30th day,60th day,90th day,120th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Above all symptoms will be decreased |
4 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
17/02/2025 |
| 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
|
Kikwisa is seen in 70 -90 %11 of all Garbhini patients attending in
Streeroga and Prasutitantra OPD. It is the major problem of modern
cosmatic conscious era. So, it requires medical treatment which is cost
effective and with less side effects .
Aaragwadha patra Kalka is mention in Vaidya Manorama and
Karveerpatra siddha taila is mention in Charaka samhita and Asthang
Hridaya for the management
of Garbhini kikwisa. By taking these drugs I
am going to prepare Taila which is easy to apply and it is cost effective
and all drugs to be used in it are easily available.
So, present study is to evaluate the role of Aaragwadha patra taila in
Garbhini kikwisa being proposed. |