| CTRI Number |
CTRI/2025/06/088844 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
04/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
COMBINED EFFECT OF SELECTED YOGA TECHNIQUES AND SHATAVARI GHEE AS NASAL DROPS IN WOMEN WITHIN THE AGE GROUP 40-55 YEARS HAVING SYMPTOMS RELATED WITH STOPPAGE OF MENSES. |
|
Scientific Title of Study
|
COMBINED EFFECT OF SELECTED YOGA TECHNIQUES AND SHATAVARI GHRITA PRATIMARSHA NASYA IN PERIMENOPAUSAL SYMPTOMS WITHIN THE AGE GROUP 40-55 YEARS. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ajunu S |
| Designation |
PG Scholar,Department of swasthavritta |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Second year PG Scholar,Department of swasthavritta, Government Ayurveda College and Hospital,Dhanwanthari Nagar, Puthiyakavu,Tripunithura Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9947991258 |
| Fax |
|
| Email |
ajunusharaf@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayan D |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda College ,Tripunithura |
| Address |
Professor
Department of swasthavritta Government Ayurveda College and Hospital,Dhanwanthari Nagar,Puthiyakavu, Tripunithura Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9447104383 |
| Fax |
|
| Email |
dr.jayan.d@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayan D |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda College ,Tripunithura |
| Address |
Professor
Department of swasthavritta Government Ayurveda College and Hospital,Dhanwanthari Nagar,Puthiyakavu, Tripunithura Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9447104383 |
| Fax |
|
| Email |
dr.jayan.d@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College and Hospital, Tripunithura Ernakulam, Kerala-682301 , India |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College and Hospital Tripunithura |
| Address |
Department of swasthavritta Government Ayurveda College and Hospital,Dhanwanthari Nagar, Puthiyakavu,Tripunithura Ernakulam Pin-682301 |
| Type of Sponsor |
Other [Government Ayurveda College, Tripunithura] |
|
|
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 Jayan D |
Government Ayurveda College and Hospital, Tripunithura |
Department of
Swasthavritta
Government Ayurveda
College and Hospital,P
uthiyakavu,Dhanwantari
Nagar, Tripunithura,
682301, Ernakulam,
Kerala,India.Ernakulam
Kerala
Ernakulam
KERALA
Ernakulam
KERALA |
9447104383
dr.jayan.d@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL COMMITTEE FOR ETHICS IN RESEARCH GOVERNMENT AYURVEDA COLLEGE TRIPUNITHURA ERNAKULAM 682301 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: RAJONASAH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Charaka Samhitha Suthrasthana Matraseeteeya Adhyaya, Procedure details: Pratimarsa Nasya with Sathavari Ghrita at 7 am for 30 days.)
(1) Medicine Name: Shatavari Ghrita, Reference: Chakradatha, Route: Nasal, Dosage Form: Ghrita, Dose: 1(ml), Frequency: od, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. Females of age group 40-55 years diagnosed to have perimenopausal symptoms
according to Green climacteric scale.
2. Subjects who are competent and willing to give consent.
3. Subject fit for pratimarsha nasya. |
|
| ExclusionCriteria |
| Details |
1.Surgical Menopause
2.Subjects undergoing hormone replacement therapy.
3.Known cases of Psychatric disorders under medication
4.Reccurent upper respiratory tract infection.
5.Sinusitis |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the combined effect of selected Yoga Techniques and Shatavari Ghrita Pratimarsha Nasya for 30 days by assessing the change in Green climacteric scale |
Treatment period- 30 days
Assessment will be done 0th, 31st and 61st day with Greene Climacteric Scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/06/2025 |
| 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="0"
Months="0"
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 clinical trial with 30 subjects will be selected from the OPD of Swasthavritta Department Govt..
Ayurveda College Tripunithura based on inclusion and exclusion criteria. Greene Climacteric scores
will be assessed before and after intervention. The subjects will be given ayurvedic
management ( selected yoga techniques and Shatavari Ghrita Pratimarsa Nasya) for 30 days.
Assessment will be done on 0 th, 31st and 61 st day. Data will be collected using a case performa.
The outcome of the study will be assessed, processed and analyzed statistically |