| CTRI Number |
CTRI/2022/03/041300 [Registered on: 23/03/2022] Trial Registered Prospectively |
| Last Modified On: |
04/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the efficacy of selected types of Pranayama in Anxiety Neurosis of working women. |
|
Scientific Title of Study
|
Study the efficacy of Kumbhak kriya selected from Kumbhak Paddhati text in the management of Anxiety Neurosis of working women with Ayurvedic perspective. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mrunal Jamdade |
| Designation |
PhD student |
| Affiliation |
School Of Ayurveda, D Y Patil Deemed to Be University. |
| Address |
Department of Swasthvritta, School Of Ayurveda, D Y Patil Deemed to Be University Sector 7, Nerul, Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
8691923339 |
| Fax |
|
| Email |
dr.mrunaljamdade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangala Wange |
| Designation |
HOD, Professor |
| Affiliation |
School Of Ayurveda, D Y Patil Deemed to Be University. |
| Address |
Department of Swasthvritta, School Of Ayurveda, D Y Patil Deemed to Be University Sector 7, Nerul, Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9833359698 |
| Fax |
|
| Email |
mangala.wange@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mrunal Jamdade |
| Designation |
PhD student |
| Affiliation |
School Of Ayurveda, D Y Patil Deemed to Be University. |
| Address |
Department of Swasthvritta, School Of Ayurveda, D Y Patil Deemed to Be University Sector 7, Nerul, Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
8691923339 |
| Fax |
|
| Email |
dr.mrunaljamdade@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swasthvritta OPD, D Y Patil Ayurvedic Hospital, D Y Patil deemed to be university, school of Ayurveda, Nerul, Navi mumbai, |
|
|
Primary Sponsor
|
| Name |
Dr Mrunal Ashay Jamdade |
| Address |
Depatment of Swasthvritta D Y Patil Deemed to be University school of Ayurveda Navi Mumbai |
| 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 Mrunal Ashay Jamdade |
D Y Patil Ayurvedic Hospital, Special OPD |
D Y Patil Ayurvedic Hospital, Swasthvritta department, OPD No 6, Nerul, Navi Mumbai.
Thane
MAHARASHTRA |
8691923339
dr.mrunaljamdade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, School Of Ayurveda, D Y Patil Deemed to Be University Sector 7, Nerul, Navi Mumbai. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F418||Other specified anxiety disorders. Ayurveda Condition: RASAVAHASROTODUSHTIH, (2) ICD-10 Condition:F418||Other specified anxiety disorders. Ayurveda Condition: Manovahastrotasdushti, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | No additional treatment | No additional treatment to comparator group. They will be observed only. | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Selected types of Pranayama will be practiced. It will be practiced as follows.
1. Pranayama will be practiced in the morning between 7-8am.
2. Time required to practice pranayama will be 15-20mins
3. Pranayama will be practiced for 5 days per week upto six weeks.
4.Patients who have attended 3sessions per week will be considered for the study. , Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Voluntarily participating in the study
2.Understanding the study completely and signed Informed Consent Form
3.Married women
4.Working women
5.Free of any other major systemic disorders
Ready to do pranayama study and diagnosed with Anxiety Neurosis |
|
| ExclusionCriteria |
| Details |
1.Refusal to participation by patient
2.Unmarried women
3.Pregnant women
4.Non working women
5.Women having age less than 25 years and more than 45 years
Having major systemic disorders other than Anxiety Neurosis |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary parameters to be assessed as follows with the help of Hamilton Anxiety rating scale
1.Anxious mood
2.Depressed mood
3.Nausea
4.Behaviour at interview |
At baseline
7th day
21st day
42nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Parameters to be assessed with the help of Hamilton anxiety rating scale.
1.Insomnia
2.Tendency to sweat
3.General fatigue |
At baseline
7th day
21st day
42nd day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 |
|
Date of First Enrollment (India)
|
30/03/2022 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 randomized controlled trial to study the efficacy of selected Kumbhak Kriya - Pranayama in Anxiety Neurosis of working women. In this study pranayama are selected from Kumbhak Paddhati book which is written by Aacharya Raghuvira. There are two groups- Experimental and Control. Patients from experimental group will do Pranayama practices. Pranayama will be practiced by patients for 6 weeks and follow up will be taken on 7th, 21st, 42nd day. Observations will be recorded as per criteria of assessment. Appropriate statistical tests will be applied to data generated through clinical trial to reach to conclusion. |