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CTRI Number  CTRI/2024/09/073275 [Registered on: 03/09/2024] Trial Registered Prospectively
Last Modified On: 02/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A STUDY TO EVALUATE THE EFFECT OF SARPAGANDHA GHANA VATI IN THE MANAGEMENT OF CHRONIC INSOMNIA 
Scientific Title of Study   A Clinical Study to Evaluate The Effect of Sarpagandha Ghana Vati in the Management of Chronic Insomnia 
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 Meghana Nambiyur 
Designation  Post Graduate Scholar 
Affiliation  Sri Jayendra Sarawathi Ayurveda College and Hospital 
Address  Room No 17 Department of Kayachikitsa Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  8097036089  
Fax    
Email  meghanavn@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pradeep Kumar Moharana 
Designation  Professor  
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Room No 17 Department of Kayachikitsa Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  9444123608  
Fax    
Email  pkm_ayur@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Meghana Nambiyur 
Designation  Post Graduate Scholar 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Room 17 Department of Kayachikitsa Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  8097036089  
Fax    
Email  meghanavn@yahoo.com  
 
Source of Monetary or Material Support  
Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpeth, Thiruvallur District, Chennai, Tamil Nadu, India 600119 
 
Primary Sponsor  
Name  Dr Meghana Nambiyur 
Address  Room No 17 Department of Kayachikitsa Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai 
Type of Sponsor  Other [Self] 
 
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 Meghana Nambiyur  Sri Jayendra Saraswathi Ayurveda College and Hospital  Room No 17 Department of Kayachikitsa Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai
Thiruvallur
TAMIL NADU 
8097036089

meghanavn@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Sri Jayendra Ayurveda College and Hospital  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
1Intervention ArmDrugClassical(1) Medicine Name: Sarpagandha Ghana Vati, Reference: Siddha Prayoga Sangraha Prathama Khanda Gutika Prakarana 24 (Sarpagandhadi Vati), Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 372(mg), Frequency: hs, Bhaishajya Kal: Grasantara bhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Lukewarm Milk), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  18 to 17 years old irrespective of age socioeconomic class gender religion or caste
Patients that meet the International Classification of Diseases 11th Edition criteria for chronic insomnia disorder
Patient with a history of insomnia more than 3 months long 
 
ExclusionCriteria 
Details  Patients younger than 18 years old and older than 70 years old
Patients with insomnia symptoms less than 3 months long
Patients diagnosed with major systemic diseases such as liver diseases and kidney diseases
Patients with a history of substance abuse
Patients diagnosed with clinical anxiety disorders clinical depression schizophrenia and bipolar disorder
Patients suffering from visceral pain
Patients on other medications for insomnia
Pregnant and lactating mothers
Patients with chronic hypotension below 100 by 60 mmHg 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To improve the time of falling asleep, improve staying asleep and improve waking up after 7 hours  This improvement is to be observed over a time period of 30 days, with a mid-trial assessment on the 15th Day, imemdiate post-trial assessment on the 31st Day, and a follow up assessment on the 46th Day. 
 
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   Phase 3 
Date of First Enrollment (India)   13/09/2024 
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  

Insomnia is the most common sleep disorder in the world. It is approximated that 10-15% of adults in the general world population suffer from chronic insomnia. Studies show that abnormal sleep patterns such as insomnia predict lower life expectancy and are more prone to affective disorders, and substance abuse. Elderly people, women, people with mental and physical disorders, those of lower socioeconomic status, night shift workers, and unemployed persons are all consistent risk factors for insomnia. Nidra is one of the Trayopastambha of Ayurveda, with Nidranasha leading to Dukkha (misery), Karshya (emaciation), and Abalam (loss of strength). It also leads to Klaibya (infertility) and Ajnanam (loss of mental efficiency). As such, the quality of life for a patient is impacted leading to diseases and other lifestyle disorders. Conventional medicine principles for chronic insomnia incorporate cognitive behavioural therapy in conjunction with pharmacological intervention such as benzodiazepines and ramelteon. In the usage of benzodiazepines, 15-40% of long-term users report having severe withdrawal symptoms after cessation, even after only a few weeks of treatment. Sarpagandha Ghana Vati is a classical formulation referred in Siddha Prayoga SangrahaTherefore,  research on efficacious, convenient formulations that ensure a healthy maintenance of sleep is the need of the hour. Hence, A Clinical Study to Evaluate the Effect of Sarpagandha Ghana Vati in the Management of Chronic Insomnia was undertaken.

 
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