| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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 Sangraha. Therefore, 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. |