| CTRI Number |
CTRI/2022/11/047028 [Registered on: 03/11/2022] Trial Registered Prospectively |
| Last Modified On: |
29/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An Ayurvedic formulation to manage the sleeplessness in old age population |
|
Scientific Title of Study
|
Efficacy of Sarpagandha Choorna Yoga in the management of Anidra (Insomnia) amongst geriatric population- A randomized controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Omkar Devidas Ingale |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi |
| Address |
Dept of Kayachikitsa-Rasayana Evam Vajikarana KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9405047189 |
| Fax |
|
| Email |
omkaringale11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kashavva Hiremath |
| Designation |
Reader |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi |
| Address |
Dept of Kayachikitsa KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9448945687 |
| Fax |
|
| Email |
drkvhiremath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kashavva Hiremath |
| Designation |
Reader |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi |
| Address |
Dept of Kayachikitsa KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9448945687 |
| Fax |
|
| Email |
drkvhiremath@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi |
|
|
Primary Sponsor
|
| Name |
Dr Omkar Devidas Ingale |
| Address |
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi |
| Type of Sponsor |
Other [Self sponsored PG dissertation work] |
|
|
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 Omkar Devidas Ingale |
KLEs Ayurveda Hospital and Research Center Shahapur Belagavi |
OPD No. 6,13,14 of KLEs Ayurveda Hospital and Research Center, KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA |
9405047189
omkaringale11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sarpagandha Ghana Vati, Reference: SiddhaYogaSangraha,19th-Bhrama-Anidra-Unmadadhikara Adhyaya & AFI-2(10:11), Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: -Nil | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sarpagandha Choorna Yoga, Reference: Siddha Yoga Sangraha, 19th-Bhrama-Anidra-Unmadadhikara Adhyaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: -Nil |
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Individuals above & equal to 60 years of age having insomnia of minimum 3 months
duration
2) Either sex
3) Insomnia Severity Index above score 7 |
|
| ExclusionCriteria |
| Details |
1) Patients with k/c/o psychiatric illness like Schizophrenia, Major depressive disorder,
Psychosis, Epilepsy, Anxiety disorders, etc.,
2) Patients with k/c/o Alcohol Dependency or Drug dependency and Hypotension.
3) Patient with other k/c/o sleep disorders like Narcolepsy, Breathing-related Sleep Disorder,
Circadian Rhythm Sleep Disorder, Parasomnia, Hypersomnolence, etc.,
4) Patients with other k/c/o illness like Asthma, Malignancies, Liver Cirrhosis, Chronic Renal
Failure, etc.,
5) Use of Hypnotics by Prescription, Psychotherapy within the past 4 weeks. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Srapagandha Choorna Yoga capsule will be helpful in the improvement of quality and quantity of sleep and quality of life amongst geriatric population and hence better management of Anidra (Insomnia) through
1)Insomnia Severity Index |
0th day 15th day and 30th day |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Srapagandha Choorna Yoga capsule will be helpful in the improvement of quality & quantity of sleep & quality of life amongst geriatric population & hence better management of Anidra (Insomnia) through
1) Ayurvedic Assessment Parameters
2) Pittsburgh Sleep Quality Index
3) Epworth Sleepiness Scale-Pictorial
4) Short Form 36 Health Survey Questionnaire (SF36)
5) Depression Anxiety Stress sacle-21
6) Geriatric Sleep Questionnaire-6 |
1)Ayurvedic Assessment Parameters
2)Pittsburgh Sleep Quality Index
3)Epworth Sleepiness Scale-Pictorial
4)Short Form 36 Health Survey Questionnaire (SF36)
these four scales will be assessed on 0th & 30th day
5)Depression Anxiety Stress sacle-21
6)Geriatric Sleep Questionnaire-6
these three parameters will be assessed for 0th day 15th day & 30th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2023 |
| Date of Study Completion (India) |
01/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Nidra (Sleep) being one of the Trayopastambhas mentioned in Ayurveda; has uttermost importance in leading healthy & satisfactory life. It is a universal behavior seen among all the higher living things and occupies about 1/3rd of human lives. It helps to maintain nutritional balance, energy, reproductive health, senses orientation and psychosomatic as well as spiritual wellbeing. Proper sleep gives Sukh (happiness), Pushti (nourishment), Bala (strength), Vrishyata (aphrodisiac), Dnyaana (knowledge), Jeevita (life); While Improper sleep or less sleep results into Dukha (unhappiness), Karshyata (emaciation), Abala (weakness), Kleebata (impotant), Adnyaana (impaired knowledge or unwise), destroys the life. So, most essential thing for survival. Among all sleep disorders (7 amongst 81 are major as per ICSD-3), Insomnia is a common and universal complaint being present in about 25-30% of the population in general; also, In the studies by Suri et al insomnia increased progressively with age being 17.3%, 28.1% & 59.0% respectively in the child, adult & elderly population respectively. Existing Indian studies of insomnia among elderly subjects are few and utilize differing samples, with reported prevalence ranging from 20% to 59%. Women are affected more commonly than men, and it increases in both sexes with age. The WHO estimates that between 2015 and 2050, the proportion of the world’s population over 60 years will nearly double from 900 million to 2 billion (12% to 22%). India has thus acquired the label of an ageing nation with 7.7% of its population being more than 60 years old. It has long been the belief that the amount of the sleep needed per night decrease with age and insomnia is a normal phenomenon with older age. But many studies have confirmed that, need for sleep may not changes with age, but the ability to get the needed sleep does decrease with age. Multiple causes could be responsible for reduced capability to achieve sufficient sleep with age, including medical or psychiatric illnesses, life changes (e.g., retirement, bereavement, decreased social interaction), environmental changes (e.g., placement in a nursing home) and polypharmacy. If insomnia is not treated, there is high risk to suffer from several psychosomatic disorders; it may reduce mental capacity of an individual, reduce efficacy and increase the chances of 5 various types of accidents. In contemporary medicine, various sedatives, tranquilizers and hypnotics drugs like zolpidem, temazepam (benzodiazepines, non-benzodiazepines) etc. are being used, but till now, no curative management for Geriatric Insomnia is found; on other hand those drugs are having huge side effects after long-term use rather that relief. So here comes the relevancy of the Ayurvedic principles to treat the insomnia. Many Ayurvedic formulations are effective in treating insomnia but there are less evidences available and less studies have been done on insomnia in Geriatric Population. It is a vulnerable population & due to vata vruddhi, pitta vitiation, dhatu-kapha kshayata they suffer from various metabolic disorders, which may in turn lead to anidra. Hence the administration of such a drug which corrects metabolism, dosh-dhatu vaishamya and induce proper sleep would be helpful and minimal quantity, acceptability, palatability of the drug is also a necessity. So, drug with Vata-Pittahara, Kaphakara, Dhatuposhaka, Mastishka Shamaka, Nidrajanaka, Nadibalya and Rasayana is to be chosen for study. Thus, this study is an effort to evaluate the effect of the drug SARPAGANDHA CHOORNA YOGA in geriatric population. |