| CTRI Number |
CTRI/2024/12/078761 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of haridra dalchini lepa with vishalmoola lepa in stanpeeda |
|
Scientific Title of Study
|
Randomized comparative study to evaluate the effect of haridra dalchini lepa with vishalmoola lepa in manegment of stanpeeda w.s.r. to cyclical mastalgia |
| 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 Aishwarya Hemant Pawar |
| Designation |
MS scholar Prasutitantra Evum Streeroga Department |
| Affiliation |
Matoshri Asrabai Darade Ayurved Hospital Afiilated With Matoshri Asrabai Darade Ayurved College |
| Address |
Matoshri Asrabai Darade Ayurved Hospital OPD N0 8 Prasutitantra Evum Streeroga OPD Ground Floor Matoshri Asrabai Darade Ayurved College SND campus Babhulgao Tal Yeola Dist Nashik
Nashik
MAHARASHTRA
423401
India |
| Phone |
7276441344 |
| Fax |
|
| Email |
paishwarya726@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipti Paithankar |
| Designation |
Associate Professor Prasutitantra Evum Streeroga Department |
| Affiliation |
Matoshri Asrabai Darade Ayurved College,Babhulgao,Yeola |
| Address |
Matoshri Asarabai Darade Ayurved hospital,OPD No.8 Prasuti tantra evam Streerog ,Ground floor ,Matoshri Asarabai Darade Ayurved college ,SND caampus,Babhulgao,Yeola
Matoshri Asarabai Darade Ayurved college,Prasuti tantra evam Streerog department,SND campus ,Bbabhulgaon ,Yeola
Nashik
MAHARASHTRA
423401
India |
| Phone |
8668735193 |
| Fax |
|
| Email |
diptisonwane3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya Hemant Pawar |
| Designation |
MS scholar Prasutitantra Evum Streeroga Department |
| Affiliation |
Matoshri Asrabai Darade Ayurved Hospital affilated with Matoshri Asrabai Darade Ayurved College |
| Address |
Matoshri Asrabai Darade Ayurved Hospital OPD N0 8 Prasutitantra Evum Streeroga OPD Ground Floor Matoshri Asrabai Darade Ayurved College SND campus Babhulgao Tal Yeola Dist Nashik
Nashik
MAHARASHTRA
423401
India |
| Phone |
7276441344 |
| Fax |
|
| Email |
paishwarya726@gmail.com |
|
|
Source of Monetary or Material Support
|
| MATOSHRI ASARABAI DARADE AYURVED COLLEGE AND MATOSHRI ASARABAI DARADE AYURVED HOSPITAL ,BABHULGAON TAL-YEOLA,DIST-NASHIK ,MAHARASHTRA ,INDIA
423401 |
|
|
Primary Sponsor
|
| Name |
Matoshree Asrabai Darade Ayurved College Babhulgao Tal-Yeola |
| Address |
Matoshree Asrabai Darade Ayurved College Babhulgao Tal-Yeola Dist.-Nashik Maharashtra India Pin-423401 |
| 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 Aishwarya Hemant Pawar |
Matoshri Asrabai Darade Ayurved College Babhulgao Yeola |
OPD NO.8 Department of Prasutitantra Evum Streeroga Matoshri Asrabai Darade Ayurved College Babhulgao Tal.-Yeola Dist.Nashik , Pin-423401
Nashik
MAHARASHTRA |
7276441344
paishwarya726@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Matoshree Asrabai Darade Ayurved College Babhulgao Yeola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N644||Mastodynia. Ayurveda Condition: STANYAVAISHAMYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: SHARANGDHAR SAMHITA , Procedure details: (Procedure Reference: sharangdhar sanhita, Procedure details: The area to be applied should be washed before application of lepa with water. Lepa should be apply in opposite direction of hair follicle (Pratiloma gati). It should be applied in premenstrual phase for 5 consecutive days ,once a day in the mornig Thickness of lepa should be 1/4th angula (0.5 cm). Gentle pressure and massage should be done. It should be left until it dries and should be removed. Wash with lukewarm water and remove the lepa ))
(1) Medicine Name: HARIDRA DALCHINI , Reference: BHARAT BHAISHJYA RATNAKAR 6860, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Duration: 5 Days | | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: SHARANGDHAR SAMHITA, Procedure details: (Procedure Reference: sharangdhar sanhita, Procedure details: The area to be applied should be washed before application of lepa with water. Lepa should be apply in opposite direction of hair follicle (Pratiloma gati). It should be applied in premenstrual phase for 5 consecutive days ,once a day in the mornig Thickness of lepa should be 1/4th angula (0.5 cm). Gentle pressure & massage should be done. It should be left until it dries and should be removed. Wash with lukewarm water and remove the lepa ))
(1) Medicine Name: VISHAL MUL , Reference: BHARAT BHAISHJYA RATNAKAR 6860, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Duration: 5 Days |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
A. Patients with cyclic/ premenstrual mastalgia in premenstrual syndrome.
B. Mastalgia severe enough to disturb the life style of a woman.
C. Patient between menarche to menapause |
|
| ExclusionCriteria |
| Details |
1)Patients suffering from hyperprolcatinaemia.
2)Patients having history of or currently suffering from any malignancy, fibrocystic
changes and breast lump.
3) Antenatal patients and lactating mothers.
4) Patients with withdrawals of oral contraceptive pills.
ï‚· Cyclic mastalgia with nodularity |
|
|
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 |
The parameters will be noted down before after treatment
1)Pain in breast
2)Breast engorgment
3)Tenderness
|
On 1st Menstrual Cycle,
2nd Menstrual Cycle,
3rd Menstrual Cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decreased symptoms completly |
3 months |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
10/01/2025 |
| 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
|
In complete lifecycle, woman goes through various phases of psychological and physiological changes. like onset of menstruation, which includes growth of mammary gland, axillary and pubic hair growth, followed by pregnancy, lactation and menopause. Breast changes (changes in breast) have been dealt with here. But in case of stappeeda which may cause engorgement, Pain in the breasts and condition which are very agonizing for the woman.According to modern Sciences, stanapeeda can be corelated with mastalgia.This stampeeda, is an unnecessary addition.to woman’s grief Taking into consideration all the above mentioned Factors, I have chosen this subject, to evaluatewhether Certain Ayurvedic preprations might help.the patient get relief from stappeeda or not.In Bharat Bhaishajya Ratnakar, certain stanapeeda Or lepa has been mentioned described under stanaRoga.An Ayurvedic prepration called Haridia and Dalchini lepa & Vishalmoola lepa is chosen for the study.
Need for study:- stanpeeda [Mastalgia ]is most neglected & less thoroughy studied subject/disease than other breast problems Approximately 70%%-80% of women experiences Severe breast pain at some time, or for some days in their lifetime Mastalgia accounts for 30% to 47%. of breast clinical evalutions. In 15% of patients, mastalgia so is so Severe that it alters day to day routine lifestyle and requires repeated visits to clinic investigations and treatment cyclic / Premenstrual mastalgia is a commonly felt diffuse or bilateral breast pain with some radiation to upper arm & axilla. Severe It can be more in one breast than in other fand is Relived by onset of menstrual flow. It is one of the most common complaints. which can only resolve with hormonal events like pregnancy ,menopause I so it is to give effective relief to patient with stappeeda, by ayurvedic prepetition Lepa’ and to evaluate effectivness of haridra dalchini lepa in comparison vishal moola lepa, this topic is chosen for the study |