| CTRI Number |
CTRI/2025/03/083018 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Mansyadi Ghanvati and night regimen with or without Bhramari Pranayama in disturbed sleep in geriatric population |
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Scientific Title of Study
|
Efficacy of Mansyadi Ghanvati and Ratricharya with or without Bhramari Kumbhaka in the Management of Mild and Short-term Insomnia in Geriatric Population - An Open Labelled Randomized Comparative Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd kapuriya dixita |
| Designation |
M.D. Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
Department of Swasthavritta Dhanvantari Mandir Institute of Teaching and Research in Ayurveda Opposite B division Police Station Jamnagar Gujarat 361008 Institute of Teaching and Research in Ayurveda Opposite B division Police Station Jamnagar Gujarat 361008 Jamnagar GUJARAT 361008 India |
| Phone |
9099236828 |
| Fax |
|
| Email |
kapuriyadixita334@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Vd Arpan A Bhatt |
| Designation |
Professor and Head |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
Department of Swasthavritta Dhanvantari Mandir Institute of Teaching and Research in Ayurveda Opposite B division Police Station Jamnagar Gujarat 361008 Institute of Teaching and Research in Ayurveda Opposite B division Police Station Jamnagar Gujarat 361008 Jamnagar GUJARAT 361008 India |
| Phone |
9998968727 |
| Fax |
|
| Email |
vdarpansoniac@itra.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Prof Arpan A Bhatt |
| Designation |
Professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
Department of Swasthavritta Dhanvantari Mandir Institute of Teaching and Research in Ayurveda Opposite B division Police Station Jamnagar Gujarat 361008 Institute of Teaching and Research in Ayurveda Opposite B division Police Station Jamnagar Gujarat 361008 Jamnagar GUJARAT 361008 India |
| Phone |
9998968727 |
| Fax |
|
| Email |
vdarpansoniac@itra.edu.in |
|
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Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda, Opposite B Division Police Station Jamnagar Gujarat 361008 |
|
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Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda |
| Address |
Opposite B Division Police Station Jamnagar Gujarat 361008 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dixita Kapuriya |
Institute of Teaching and Research in Ayurveda |
Department of Swasthavritta Institute of Teaching and Research in Ayurveda Opposite B division Police Station Jamnagar
Jamnagar GUJARAT |
9099236828
kapuriyadixita334@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute of Teaching and Research in Ayurveda (INI) Jamnagar Gujarat 361008 |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mansyadi Ghanvati, Reference: Yadvaji Trikamji Acharya Siddha yoga sangraha 8th ed.Nagpur: Shri Baidyanath Ayurveda Bhavan Ltd;1984 p. 86, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: Nil | | 2 | Intervention Arm | Procedure | - | Bhramari Kumbhaka | (Procedure Reference: Hath Yoga Pradipika, Procedure details: Prana Dharana, Nadi Shodhana, Bhramari Kumbhaka 5 cycles for first 15 days,7 cycles for second 15 days,11 cycles for third 15 days 15 cycles for last 15 days.)
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Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Age group - 60-80 years
2 Patients of mild and short-term insomnia.
3 Patients willing to accept the participation in clinical trial.
4 Individuals with controlled primary systemic diseases.
|
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| ExclusionCriteria |
| Details |
1 Age below 60 years and above 80 years.
2 Patients suffering from chronic insomnia disorder.
3 Patients suffering from severe or moderate insomnia.
4 Secondary Insomnia.
5 Fatal Familial Insomnia.
6 Patients with alcohol or drug dependency.
7 Advanced chronic illnesses such as bronchial asthma, diabetes, cancer, liver cirrhosis, chronic renal failure.
8 Acute illnesses such as cerebrovascular accidents, myocardial infarction, COPD, epilepsy.
9 uncontrolled systemic diseases like Diabetes (Random Blood sugar not more than 200 mg/dl), hypertension (not more than 180/100 mm Hg).
10 Patients with major psychiatric illnesses like schizophrenia, depressive psychosis, bipolar disorders, obsessive compulsive disorder, personality disorders, mood disorders, panic disorders, post-traumatic stress disorders.
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| •Improvement in quality of sleep of the patients with mild and short Insomnia in geriatric population according to ICSD criteria. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Improvement in associated complains of Anidra.
•Improvement in the level of stress.
|
8 weeks |
|
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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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2025 |
| 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="1" Months="1" Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Introduction: Nidra is considered one of the most important aspects of a relaxed state of mind and overall health. Acharya Charaka highlights the role of Kala and Vata in regulating Nidra and Anidra. Vata, with its Chala Guna, disrupts Mana’s rest, contributing to Anidra, especially in Vata-dominant period of aging and causes insomnia in geriatric population. In Ayurvedic classics, various treatment modalities for Anidra like Lifestyle modifications, Dietary changes, Medications, Panchakarma therapies, etc. Medications like Mansyadi Ghanvati have Nidrajanaka, Balya, and Vatahara properties. Lifestyle modifications such as Ratricharya, Dinacharya are emphasized in the classics, with Ratricharya being particularly important for promoting health. Pranayama has recently gained more popularity because of its multifold health benefits. It is believed that one can control the power of mind through regulating the breath. Among the different types of Kumbhaka, Bhramari Kumbhaka is stated the best to give a blissful condition of mind. Rationale For Selection of Topic: Insomnia complaints are more prevalent among older adults. The type of insomnia symptom changes as a function of age, with difficulties initiating sleep being more common among young adults and problems maintaining sleep occurring more frequently among middle-age and older individuals. Overall, the prevalence of insomnia symptoms ranges from 30% to 48% in the elderly, whereas the prevalence of insomnia symptom disorder ranges from 12% to 20%. Sleep maintenance symptoms are more prevalent among individuals with insomnia (50%-70%), followed by difficulty in initiating sleep (35%-60%) and non-restorative sleep (20%-25%). Aim and Objectives: To evaluate the efficacy of Mansyadi Ghanvati and Ratricharya with Bhramari Kumbhaka in the management of mild and short-term insomnia in geriatric population.Materials and Methods: 30 patients of mild and short-term insomnia in geriatric population will be enrolled in two groups. In Group A(Trial Group ) will be taken Mansyadi Ghanvati and Ratrichrya with Bhramari Kumbhaka 5 cycles in the first 15 days, 7 cycles for 2nd 15 days, 11 cycles for 3rd 15 days and 15 cycles for last 15 days, while in Group B( Comparative Group ) will be taken Mansyadi Ghanvati and Ratricharya. Results and Discussion: Data generated during the above study will be present in a Systemic manner as shall be analyzed statically. Where the important points of the review of literature, Conceptual study, Analytical study will be discussed. Follow up: Patients will be advised to visit the hospital every 15 days during the treatment for 8 weeks and after the completion of therapy for the duration of after 15 days for one month as a follow up. |