| CTRI Number |
CTRI/2024/06/069071 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Nutraceutical |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Add on effect of selected yoga techniques with suntyadi powder candy for the management of irregular menstrual periods in polycystic ovarian syndrome |
|
Scientific Title of Study
|
Add on effect of selected yoga techniques with suntyadi churna candy for the management of oligomenorrhea in polycystic ovarian syndrome |
| 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 Divya V G |
| Designation |
PG scholar, Department of Swasthavritta |
| Affiliation |
Government Ayurveda Medical College and Hospital |
| Address |
Department of Swasthavritta, OP No 2, Government Ayurveda Medical College and Hospital,Pulimoodu junction,Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9400715574 |
| Fax |
|
| Email |
dew.divvu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya V G |
| Designation |
PG scholar, Department of Swasthavritta |
| Affiliation |
Government Ayurveda Medical College and Hospital |
| Address |
Department of Swasthavritta, OP No 2, Government Ayurveda Medical College and Hospital,Pulimoodu junction,Thiruvananthapuram
KERALA
695001
India |
| Phone |
9400715574 |
| Fax |
|
| Email |
dew.divvu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sheela S |
| Designation |
Professor and HOD, Department of Swasthavritta |
| Affiliation |
Govt Ayurveda Medical College and Hospital |
| Address |
Department of Swasthavritta, OP No 2, Government Ayurveda Medical College and Hospital,Pulimoodu junction,Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9847706888 |
| Fax |
|
| Email |
drsheelas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Ayurveda Medical College and Hospital, Thiruvananthapuram, pin 695001, Kerala, India |
|
|
Primary Sponsor
|
| Name |
Dr Divya V G |
| Address |
PG Scholar,Govt Ayurveda Medical College and Hospital,Thiruvananthapuram, pin 695001, Kerala, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Divya V G |
Government Ayurveda Panchakarma Hospital |
Department of Swasthavritta, OP No 2 ,Poojappura, Thiruvananthapuram, Kerala
Thiruvananthapuram
KERALA |
9400715574
dew.divvu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE(IEC),Gov t ayurveda college,Thiru vanathapuram,Kerala,India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Suntyadi churna candy, Reference: Ashtanga Hridaya Chikitsa stana 14/41, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Suntyadi churna candy, Reference: Ashtanga Hridaya Chikitsa stana 14/41, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: Selected yoga techniques are also given |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Known cases of PCOS diagnosed as Oligomenorrhoea with more than 35 days of bleeding interval for more than three consecutive menstrual cycles in the age group 18-35 years
|
|
| ExclusionCriteria |
| Details |
1) Known cases of structural uterine abnormalities and chronic systemic illnesses on medication.
2) Secondary dysmenorrhoea.
3) Thyroid dysfunction
4) Primary amenorrhea
5) Concurrent or previous use of oral contraceptive pills within last 3 months
6) Known cases of androgen producing adrenal tumour and other neoplastic growth
7) Participants with heavy menstrual bleeding.
8) Pregnancy and lactating mothers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the menstrual interval |
0th, 91st and 120th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in duration of bleeding
Changes in amount of bleeding |
0th, 91st and 120th day |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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 Yet Recruiting |
| 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
|
Polycystic ovarian syndrome is a heterogeneous disorder characterised by excessive androgen production by the ovaries mainly. It is a multifactorial and polygenic condition. Oligomenorrhea and or anovulation, clinical and or biochemical hyperandrogenism, ultrasound appearance of polycystic ovaries are the criterion for diagnosing PCOS. Menstrual bleeding occurring more than 35 days apart and which remains constant at that frequency is called oligomenorrhea. Ayurveda and yoga have pivotal role in the treatment and prevention of Oligomenorrhea. Yogasanas help to stimulate the functions of the reproductive organs, relieves menstrual discomfort and normalizes the menstrual cycle, increases blood flow to the reproductive organs and enhances the functions of the ovaries. Suntyadi churna is already proven for oligomenorrhea. This study aims at finding the add on effect of selected yoga techniques in oligomenorrhea associated with PCOS. It will be a quasi-experimental study with control group with a sample size of 46 cases with 23 in each group in women aged 18-35 years from Govt. Ayurveda Panchakarma Hosptal, Poojappura, Thiruvananthapuram. After collecting the baseline data of subjects, for the study group, selected yoga techniques along with suntyadi churna candy will be given at a dose of 12 gms before food twice daily and luke warm water as anupana and for control group suntyadi churna candy alone. Total duration of the intervention will be 3 months, excluding menstruation days. Menstrual interval, duration and amount of bleeding of each cycle of patients will be assessed on 0th ,91st, and120th day. |