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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  
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 
 
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  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda, Opposite B Division Police Station Jamnagar Gujarat 361008 
 
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 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(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
2Intervention ArmProcedure-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.)
 
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.
 
 
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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
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 
 
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 
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  

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 RatricharyaResults 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 discussedFollow 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.

 
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