| CTRI Number |
CTRI/2018/02/012037 [Registered on: 21/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
20/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial on dysmenorrhea |
|
Scientific Title of Study
|
A pilot study of sotru uppu Adhi chenthooram for the treatment of Primary dysmenorrhea(Aga soodhaga vali) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMAmala hazel |
| Designation |
lecturer |
| Affiliation |
National institute of siddha |
| Address |
National institute of siddha
department of kuzhandhai maruthuvam
tambaram sanatorium
chennai
National institute of siddha
department of kuzhandhai maruthuvam
tambaram sanatorium
chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9940429202 |
| Fax |
|
| Email |
dramalaaruldhas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
TKKalyana sundaram |
| Designation |
Former head of the department(kuzhandhai maruthuvam) |
| Affiliation |
National institute of siddha |
| Address |
National institute of siddha
department of kuzhandhai maruthuvam
tambaram sanatorium
chennai
National institute of siddha
department of kuzhandhai maruthuvam
tambaram sanatorium
chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9444946270 |
| Fax |
|
| Email |
kalyas53@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
TKKalyana sundaram |
| Designation |
Former head of the department(kuzhandhai maruthuvam) |
| Affiliation |
National institute of siddha |
| Address |
National institute of siddha
department of kuzhandhai maruthuvam
tambaram sanatorium
chennai
National institute of siddha
department of kuzhandhai maruthuvam
tambaram sanatorium
chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9444946270 |
| Fax |
|
| Email |
kalyas53@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
National institute of siddha |
| Address |
National institute of siddha
ayothidhass pandithar hospital
tambaram sanatorium
chennai 600047 |
| 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 |
| DrAMAmala Hazel |
National Institute of siddha |
National Institute of siddha
tambaram sanatorium
chennai 600047
Chennai
TAMIL NADU |
9940429202
dramalaaruldhas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
pain present in the lower abdomen during mensturation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
sotruppu chendooram |
oral administration 4.2 grams o.d for 3 days |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Age between 11 to 25 years.
Nulliparous women.
Patient willing to Ultrasound abdomen and blood investigations.
Spasmodic dysmenorrhoeal pain ranging from 4-10 according to Numerical Rating Pain Scale.
Patient willing to sign the informed consent
|
|
| ExclusionCriteria |
| Details |
Presence of any pelvic pathology such as Chronic pelvic infection, Pelvic endometriosis, Adenomyosis, Uterine fibroid, Endometrial Polyp,
IUCD in utero.
Presence of any associated severe systemic illness.
Abdominal pain presenting other than the period of menstruation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Significant outcome - Reduction of lower abdominal pain from 4-10 to 0 in the pain scale
Good outcome - Reduction of pain from 7-10 to1 – 3
Moderate outcome - Reduction of pain from 4-6 to1 – 3 and from 7-10 to 4-6.
|
3-5 days of menstruation and premenstrual period
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the menstrual pain in successive 3 cycles |
3 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/10/2016 |
| Date of Study Completion (India) |
10/10/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
it is an open clinical trial to evaluate the therapeutic efficacy of sotruppu chenduram internal medicine from the siddha text pulipaani vaithiyam 500.the treatment will be given for 3 days 4.2grams orally o.d with vellaipoondu thailam the lab investigations and clinical assessment will recorded periodically before and after treatment period.all the trial related data will be recordered in Case Report Form (CRF) for each patient seperately. At the end of trial all the data will be analysed statistically and the research reports will be published |