| CTRI Number |
CTRI/2021/08/035383 [Registered on: 04/08/2021] Trial Registered Prospectively |
| Last Modified On: |
03/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Attathi chooranam and Yoga theropy for PCOS |
|
Scientific Title of Study
|
PHASE II NONRANDOMIZED COMPARATIVE OPEN CLINICAL EVALUATION ON “SOOTHAGA VAAYU†(POLYCYSTIC OVARIAN SYNDROME) TREATED WITH “SIDDHAR YOGA THERAPY†AND (INTERNAL) “ATTATHI CHOORANAM†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gurulakshmi Alias Kavitha R |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College Chennai |
| Address |
Post graduate Room No.S3,
Department of Siddhar Yoga Maruthuvam,
Government Siddha Medical College, Chennai 106
Chennai, TAMIL NADU - 600106
India
Chennai
TAMIL NADU
600106
India |
| Phone |
9940176693 |
| Fax |
|
| Email |
kavikesav25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saibudeen K |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
Government Siddha Medical College Chennai |
| Address |
Post graduate Head of The Department
Department of Siddhar Yoga Maruthuvam
Government Siddha Medical College Chennai 106
Chennai
TAMIL NADU
600106
India
Chennai
TAMIL NADU
600106
India |
| Phone |
9486041993 |
| Fax |
|
| Email |
drsaibudeen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gurulakshmi Alias Kavitha R |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College Chennai |
| Address |
Post graduate Room No.S3,
Department of Siddhar Yoga Maruthuvam,
Government Siddha Medical College, Chennai 106
Chennai, TAMIL NADU - 600106
India
Chennai
TAMIL NADU
600106
India |
| Phone |
9940176693 |
| Fax |
|
| Email |
kavikesav25@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT SIDDHA MEDICAL COLLEGE,CHENNAI |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
6,Anna Arch Road NSK Nagar Arumbakkam Chennai -600106 |
| Type of Sponsor |
Government 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 Gurulakshmi Alias Kavitha R |
Government Siddha Medical College |
Post Graduate Room No.S3,
Department of Siddhar Yoga Maruthuvam
Chennai
TAMIL NADU |
9940176693
kavikesav25@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: N830||Follicular cyst of ovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Internal
Attathi chooranam
External
ASANAS (Pathahastasanam,Trikonasanam,Patchimottasanam,Bhujangasanam,Baddha konasanam,Halasanam and Savasanam)
PRANAYAMAM (Naadi sudhi pranayamam )
DHIYANAM (AUM Chanting) |
Internal
Attathi chooranam (4 - 6 gms twice in a day with honey)
External (40 mins in a day)
ASANAS (Pathahastasanam,Trikonasanam,Patchimottasanam,Bhujangasanam,Baddha konasanam,Halasanam and Savasanam)
PRANAYAMAM (Naadi sudhi pranayamam )
DHIYANAM (AUM Chanting)
|
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Primary infertility
Irregular menstruation(Oligomenorrhoea/Amenorrhoea /Dysmenorrhoea/Dysfunctional Uterine Bleeding)
Obesity
|
|
| ExclusionCriteria |
| Details |
Recent hormone therapy (Past one year)
Uterine anomalies (infantile uterus)
Auto Immune disease
Hyperthyroidism/Hypothyroidism
Diabetes mellitus
Haemorrhagic cyst
Chocolate cyst
Tuberculosis of the ovary and uterus
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Regulation of ovulation and disappearance or reduction in the size and number of cyst while diagnosis through USG Pelvis after 3 months of treatment. |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome is assessed by comparing the quality of patient wellness before and after treatment. |
90 days |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
31/08/2021 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a single Non-Randomized Open Clinical Trial to study the safety and efficacy of siddha trial drug Attathi Chooranam (internal) is to be given about 1 – 1 ½ varagan (4 - 6 gms) twice a day for 3 Months and Siddhar Yoga Therapy (external) for 3 Months. During the trial study related data will be recorded and documented. After the completion of trial all data will be statistically analysed. |