| CTRI Number |
CTRI/2025/04/085411 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
17/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the effect of yog module in katishool of menopausal females. |
|
Scientific Title of Study
|
A single arm clinical study to evaluate the effect of yog module in katishool of menopausal females in Pune region. |
| 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 Sonal Shriprasad Tinaikar |
| Designation |
PG Student |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalay, Hadapsar |
| Address |
Special OPD no.3, Department of Swasthavritta, Sane guruji Arogya Kendra, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8149224742 |
| Fax |
|
| Email |
sonaltinaikar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roma Gangawane |
| Designation |
Asst. Prof. Of Department of Swasthavritta and Yoga |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalay, Hadapsar |
| Address |
Special OPD no.3, Department of Swasthavritta, Sane guruji Arogya Kendra, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9822007402 |
| Fax |
|
| Email |
roma.gangawane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roma Gangawane |
| Designation |
Asst. Prof. Of Department of Swasthavritta and Yoga |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalay, Hadapsar |
| Address |
Special OPD no.3, Department of Swasthavritta, Sane guruji Arogya Kendra, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9822007402 |
| Fax |
|
| Email |
roma.gangawane@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Swasthavritta and Yoga, Sane guruji Arogya Kendra, Malwadi, Hadapsar, Pune. Pincode - 411028 |
|
|
Primary Sponsor
|
| Name |
Sane guruji Arogya Kendra |
| Address |
Department of Swasthavritta and Yoga,Sane guruji Arogya Kendra, Hadapsar, Pune 28 |
| 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 |
| Dr Sonal Tinaikar |
Sane guruji Arogya Kendra, Hadapsar, Pune |
Special OPD no 3, Department of Swasthavritta and Yoga, Sane guruji Arogya Kendra, Hadapsar, Pune
Pune
MAHARASHTRA |
8149224742
sonaltinaikar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMS Sumatibhai Shah Ayurved Mahavidyalay and Sane guruji Arogya Kendra, Hadapsar, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M955||Acquired deformity of pelvis. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:5 Asanas including Paschimottanasana, Pavanmuktasana, Ushtrasana, Bhujangasana, Shalabhasana.
2 rounds and time duration of 3 min for each Asana., Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Females who have not experienced menstrual cycle for consecutive 12
months.
Score of VAS scale : 1 to 8
Score of Oswestry Disability Index : 5 to 24
History of low back pain for more than 1 month. |
|
| ExclusionCriteria |
| Details |
Subjects with severe low back pain due to anatomical / systemic pathology
or due to accident
Subjects with recent surgery or recommended surgical intervention
Subjects with known case of major systemic illness
Subjects with surgical menopause (bilateral oophorectomy with or without
hysteroctomy) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
A single arm clinical study to evaluate the effect of Yog module in Katishool of menopausal females.
The parameters of efficacy will be evaluated by observing the patient through subjective and objective criteria at regular intervals 0th, 15th, 30th days follow up. The relief of Katishool will be analysed with the help of VAS scale and Oswestry Disability Outcome will be evaluated on 0th, 15th 30th day of session. |
A single arm clinical study to evaluate the effect of Yog module in Katishool of menopausal females.
The parameters of efficacy will be evaluated by observing the patient through subjective and objective criteria at regular intervals 0th, 15th, 30th days follow up. The relief of Katishool will be analysed with the help of VAS scale and Oswestry Disability Index. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To explore and promote benefits of Asanas mentioned in Ayurved and Yog. |
Total no of sessions - 30
Time period for each session - 30 min |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
04/05/2025 |
| 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 Applicable |
| 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
|
A single arm clinical study to evaluate the effect of Yog module in Katishool of menopausal females. The parameters of efficacy will be evaluated by observing the patient through subjective and objective criteria at regular intervals 0th, 15th, 30th days follow up. The relief of Katishool will be analysed with the help of VAS scale and Oswestry Disability Index. |