| CTRI Number |
CTRI/2022/11/047474 [Registered on: 21/11/2022] Trial Registered Prospectively |
| Last Modified On: |
06/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Yogic practices for womens health |
|
Scientific Title of Study
|
EFFECT OF YOGIC PRACTICES ON PHYSIOLOGICAL AND BIOCHEMICAL PARAMETERS OF ADULT FEMALES WITH RESPECT TO LEUCORRHOEA DISORDER |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AKANKSHA MITTAL |
| Designation |
PHD SCHOLAR |
| Affiliation |
LAKSHMIBAI NATIONAL INSTITUTE OF PHYSICAL EDUCATION, GWALIOR |
| Address |
DEPARTMENT OF YOGIC SCIENCES, LAKSHMIBAI NATIONAL INSTITUTE OF PHYSICAL EDUCATION, RACECORSE ROAD, MELA ROAD , SHAKTI NAGAR, GWALIOR
Gwalior
MADHYA PRADESH
474002
India |
| Phone |
7903316491 |
| Fax |
|
| Email |
AKANKSHAMITTAL9497@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nibu R Krishna |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
LAKSHMIBAI NATIONAL INSTITUTE OF PHYSICAL EDUCATION, GWALIOR |
| Address |
DEPARTMENT OF YOGIC SCIENCES, LAKSHMIBAI NATIONAL INSTITUTE OF PHYSICAL EDUCATION, RACECORSE ROAD, MELA ROAD , SHAKTI NAGAR, GWALIOR
Gwalior
MADHYA PRADESH
474002
India |
| Phone |
9425712188 |
| Fax |
|
| Email |
niburkrishna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AKANKSHA MITTAL |
| Designation |
PHD SCHOLAR |
| Affiliation |
LAKSHMIBAI NATIONAL INSTITUTE OF PHYSICAL EDUCATION, GWALIOR |
| Address |
DEPARTMENT OF YOGIC SCIENCES, LAKSHMIBAI NATIONAL INSTITUTE OF PHYSICAL EDUCATION, RACECORSE ROAD, MELA ROAD , SHAKTI NAGAR, GWALIOR
Gwalior
MADHYA PRADESH
474002
India |
| Phone |
7903316491 |
| Fax |
|
| Email |
AKANKSHAMITTAL9497@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| LAKSHMIBAI NATIONAL INSTITUTE OF PHYSICAL EDUCATION, GWALIOR |
|
|
Primary Sponsor
|
| Name |
Dr Nibu R Krishna |
| Address |
LAKSHMIBAI NATIONAL INSTITUTE OF PHYSICAL EDUCATION, GWALIOR |
| 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 |
| AKANKSHA MITTAL |
DR. KAUL HOSPITAL AND RESEARCH CENTRE |
ROOM NO. 301, DR. KAUL HOSPITAL AND RESEARCH CENTRE, NEAR NAYA BAZAR, MAIN ROAD, INDRA COLONY, CAMPU, LASHKAR, GWALIOR, MADHYA PRADESH, 474009
Gwalior
MADHYA PRADESH |
7903316491
AKANKSHAMITTAL9497@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Dr Kaul Hospital and Research Centre |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N898||Other specified noninflammatory disorders of vagina, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Active Control Group |
Active Control Group participants will continue their regular activities including walking. |
| Intervention |
YOGIC PRACTICES |
PRAYER, LOOSENING PRACTICES, SURYA NAMASKAR, ASANA, PRANAYMA, BANDHAS, CONCENTRATION |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients will be selected on the basis of wet vaginal smear and observation by doctor.
2. Infertile female will be included in this study.
3. If any one of Trichomonas vaginalis or Fungal Hyphae or pus cells is present in the wet vaginal smear then those patients will be register.
4. Participants who had undergone surgeries in are included.
5. Patients suffering from Tuberculosis, Sexually Transmitted Diseases like VDRL, Gonorrhoea, etc. and Genital malignancy, Congenital and any other pathologies of reproductive tract will be included. |
|
| ExclusionCriteria |
| Details |
1. Pregnant women are excluded.
2. Patients who suffer with neurocognitive disorders are also excluded.
3. Physically handicapped patients are also excluded.
4. Participants who continued their regular consumption of steroid drugs, contraceptive Pills and Viagra Pills are also excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. PHYSIOLOGICAL PARAMETERS INCLUDED COLOR, ODOR, AMOUNT AND ASSOCIATED SYMPTOMS
2. BIOCHEMICAL PARAMETERS INCLUDE VAGINAL CULTURE, VAGINAL SMEAR AND IMBALANCE OF VARIOUS GONAD HORMONES (MAJORLY ESTROGEN AND PROGESTERONE) |
12 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| LOWER ABDOMINAL PAIN AND QUALITY OF LIFE |
DAY 1 AND DAY 90 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/12/2022 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS STUDY IS THE RANDOMIZED PARALLEL GROUP, ACTIVE CONTROL TRIAL FOR THE PATIENT OF LEUCORRHOEA DISORDER. THE PRIMARY AND SECONDARY OUTCOME MEASURE WILL BE COMPLETED IN 12 WEEKS. PATIENT WILL FOLLOW A UNIQUE YOGA MODULE WHICH HAS BEEN DEVELOPED BY PRINCIPAL INVESTIGATOR. DURATION OF YOGIC MODULE WILL BE 45 TO 50 MINUTES. THE STUDY WILL BE DELIMITED TO THE AGE OF SUBJECT RANGE BETWEEN 15 TO 35 YEARS.THE MAIN OBJECTIVE OF THE STUDY IS TO SEE THE EFFECT OF YOGIC PRACTICES ON IMMUNO RESPONSE IN THE CONDITION OF LEUCORRHOEA DISORDER. TO SEE THE IMPACT OF YOGIC PRACTICES ON PHYSICAL AND MENTAL HEALTH OF THE PATIENTS AND THIS STUDY MAY BRING CONSCIOUSNESS/ AWARENESS AMONG FEMALE REGARDING LEUCORRHOEA DISORDER. |