| CTRI Number |
CTRI/2020/05/025058 [Registered on: 06/05/2020] Trial Registered Prospectively |
| Last Modified On: |
23/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect of Chandrashoor ladu( dietary supplement) on minimising menstrual period related pain. |
|
Scientific Title of Study
|
An exploratory clinical trial to evaluate role of Chandrashoor(Lepidium sativum Linn.) Ladu in Kashtartava(Primary Dysmenorrhea) as Shoolaghna. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Supriya Dileep Sanap |
| Designation |
MD final year |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
College of Ayurved and Research Centre,Swasthavritta department,Akurdi,Sector 25,Nigdi,Pune.
Ayurved Rugnalaya and Multi speciality Hospital,Sector 27,Pradhikaran,Akurdi,Nigdi,Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
7709073146 |
| Fax |
|
| Email |
supriyasanap5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arti Firke |
| Designation |
Assistant Professor, Department of Swasthvritta |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
College of Ayurved and Research Centre,Swasthvritta department,Akurdi,Sector 25,Nigdi,Pune.
Ayurved Rugnalaya and Multi speciality Hospital,Sector 27,Pradhikaran,Akurdi,Nigdi,Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
8888845674 |
| Fax |
|
| Email |
arfirke@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Supriya Sanap |
| Designation |
MD Final Year |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
College of Ayurved and Research Centre,Swasthvritta department,Akurdi,Sector 25,Nigdi,Pune.
Ayurved Rugnalaya and Multi speciality Hospital,Sector 27,Pradhikaran,Akurdi,Nigdi,Pune.
Pune
MAHARASHTRA
411041
India |
| Phone |
7709073146 |
| Fax |
|
| Email |
supriyasanap5@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Ayurved and Research Centre,Akurdi,Pune,411044 |
|
|
Primary Sponsor
|
| Name |
CARC |
| Address |
Pradhikaran,Sector 25,Nigdi,Pune,411044. |
| 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 Supriya Dileep Sanap |
PDEA College of Ayurved and Research Centre. |
Sector no. 25,Pradhikaran,Nigdi,Pune-411044.
Pune
MAHARASHTRA |
7709073146
supriyasanap5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable. |
Not applicable. |
| Intervention |
Use of Chandrashoor(Lepidium sativum Linn.)Ladu
Ingredients- Chandrashoor,Jaggery,Coconut and Ghritam(ghee). |
In this study, Chandrashoor Ladu 30gm/day will be given to the patients of primary dysmenorrhea before morning meal for two months. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients with chief complaint of painful menses and associated symptoms at least for three cycles.
2.Patients with pain for at least for first 2 days of the cycle.
3.Nulliparous females.
4.Age group-15 to 28 years irrespective of caste and religion. |
|
| ExclusionCriteria |
| Details |
1.Patients with chronic illness for example, DM and any systemic disorder.
2.Any diagnosed uterine pathology (Menorrhagia,Fibroid,Adenomycosis, Endometriosis).
3.Patients undergoing hormonal treatment for Dysmenorrhea.
4.Patients with Pitta Prakruti.
5.Patients with heavy menstrual bleeding.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate role of chandrashoor Ladu in minimising spasmodic pain caused by kashtartava(primary dysmenorrhea). |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate role of Chandrashoor Ladu in minimising Kashtartava(primary dysmenorrhea) associated symptoms. |
2 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
03/11/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1. Primary dysmenorrhea is the commnest among menstruation related conditions. There are chances of increase in prevalence of primary dysmenorrhea in future due to consistently changing lifestyle. 2. Currently available treatment for dysmenorrhea includes use of NSAIDs, oral contraceptive medications, prostaglandin synthetase inhibitors ; if taken for longer periods may shoew potential side effects. While Ayurvedic treatments like pichu, swedana, basti etc. are not always feasible for patients. 3. Hence there is a need to find an easy solution. Adding certain food preparations in diet can improve the condition. Literature and previous study have proved effectiveness of Chaturbeeja (a set of four seeds) in relieving spasmodic pain.Chandrashoor ( Lepidium sativum Linn.) is one of content of Chaturbeeja. 4. Therefore this study will assess effect of Chandrashoor ( Lepiduim sativum Linn. ) to relieve spasmodic pain of primary dysmenorrhea and minimize associated symptoms if added in diet in the form of ladu. |