| CTRI Number |
CTRI/2025/10/095548 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
01/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative effect of Sahadevi Ghan Vati and Tablet Zolpidem in the treatment of Primary Insomnia |
|
Scientific Title of Study
|
Evaluation of the comparative efficacy of Sahadevi Ghan Vati versus
Tablet Zolpidem in the management of Anidra ( Primary Insomnia)- A
Randomized Controlled 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 |
Dr Gauri Thakre |
| Designation |
PG SCHOLAR |
| Affiliation |
Room no 3Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha |
| Address |
Room no 30 Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9579017559 |
| Fax |
|
| Email |
gaurithakre22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sourabh Deshmukh |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha |
| Address |
Room no 30 Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9404337799 |
| Fax |
|
| Email |
ayurrulz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gauri Thakre |
| Designation |
PG SCHOLAR |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha |
| Address |
Room no 30 Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9579017559 |
| Fax |
|
| Email |
gaurithakre22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod H Wardha |
| Address |
Room no 30 Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha 442001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Gauri Thakre |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha 442001
Wardha
MAHARASHTRA |
9579017559
gaurithakre22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha |
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 (Non Ayurveda) | | - | TABLET ZOLPIDEM 10 MG | 10 mg 1Tab HS WITH WATER | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sahadevi ghan vati, Reference: Shodhal nighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: hs, Bhaishajya Kal: Antarabhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: water), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Informed Consent: Ability and willingness to provide written informed consent.
2. Patients of either sex, between the age group 18 and 65 years
3. Diagnosis: Primary insomnia as per DSM-IV-TR criteria
4. Insomnia Severity Index (ISI) Greater than 7
5. Sleep latency greater than 30 minutes
6. Total sleep time less than 6 hours per night
7. Duration Symptoms present for at least 1 month
|
|
| ExclusionCriteria |
| Details |
Anidra due to alcohol or drug abuse
2. Insomnia with major psychiatric illness like schizophrenia, depressive psychosis, epilepsy,
bipolar disorder etc.
3. Patients with drug dependency were excluded.
4. Patients having acute illness like cardiovascular accidents, myocardial infarction and chronic
obstructive pulmonary diseases.
5. Pregnant or lactating women.
6. Participation in another clinical trial within the past 3 months
7. Use of sedative-hypnotic medication within 1 week prior to the study.
8. Other sleep disorders (e.g., sleep apnea, narcolepsy, restless leg syndrome).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Enhance sedative effect of Sahadevi Ghan Vati in the management of Anidra (Primary
Insomnia) |
In 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improved sleep quality |
30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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="2"
Months="0"
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
|
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computerized generated table. Clinical Research format will be prepared and validated . Prior To study approval will be taken From IEC MGACHRC Salod (H) and CTRI registeration will be done . After selection each participants will be tested individually and selected to criteria . They are divided into two groups . The trial is Open labelled equivalence Clinical Controlled Trial. It will include a 30 days treatment period and 15th and 30th day will be Follow up period
|