| CTRI Number |
CTRI/2025/08/093379 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role Of The Go-dugdha And Mahish-dugdha Paan In The Management Of Nidranash w.s.r To Insomnia. |
|
Scientific Title of Study
|
To evaluate the efficacy of Go-Dugdha and Mahish-Dugdha paan in management of Nidranash w.s.r. to Insomnia in Adults |
| 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 Abhishek Kumar Sahu |
| Designation |
PG Scholar |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhopal |
| Address |
Third floor department of samhita siddhant ayurvedic medical college hospital and research centre bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
7000742905 |
| Fax |
|
| Email |
Abhisahu.as74@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Kumar Sahu |
| Designation |
PG Scholar |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhopal |
| Address |
Third floor department of samhita siddhant ayurvedic medical college hospital and research centre bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
7000742905 |
| Fax |
|
| Email |
Abhisahu.as74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namrata Chouragade |
| Designation |
MD(Ayu), Head Of Department |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhopal |
| Address |
Third floor department of samhita siddhant ayurvedic medical college hospital and research centre bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
7875600033 |
| Fax |
|
| Email |
Chouragade21namrata@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mansarovar Ayurvedic Medical College Hospital And Research Centre,Bhopal 462042 Madhya Pradesh India. |
|
|
Primary Sponsor
|
| Name |
Mansarovar Ayurvedic Medical College Hospital And Research Centre |
| Address |
Third Floor Department Of Samhita Siddhant Mansarovar Ayurvedic Medical College Hospital And Research Centre Hinotiya Alam Kolar Road Bhopal Madhya Pradesh |
| Type of Sponsor |
Other [Research instituition 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 Abhishek kumar sahu |
Mansarovar Ayurvedic Medical College Hospital And Research Centre,bhopal |
Third floor Department Of Samhita Siddhant Bhopal Madhya Pradesh 462042 India
Hoshangabad
MADHYA PRADESH
Bhopal
MADHYA PRADESH |
7000742905
abhisahu.as74@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Mansarovar Ayurvedic Medical College Hospital And Research Centre Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F01-F99||Mental, Behavioral and Neurodevelopmental disorders. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mahish dugdha, Reference: Acharya charak, Route: Oral, Dosage Form: Ksheerpaka, Dose: 250(ml), Frequency: hs, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 60 Days, Reference: No, Route: NA, Dosage Form: Ksheerpaka, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Go-dugdha, Reference: Acharya dalhan, Route: Oral, Dosage Form: Ksheerpaka, Dose: 250(ml), Frequency: hs, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 60 Days, Reference: No, Route: NA, Dosage Form: Ksheerpaka, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
person suffering from nidranash(insomnia) |
|
| ExclusionCriteria |
| Details |
Adult suffering from any known systemic disorder or chronic illlness affecting nidra.
Person having addiction of any type or suffering from mental disabilities.
Adult practising nidra viparyaya i.e; diwaswapna, ratrijagran etc on regular basis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Effect Of Go-dudha paan And Mahish Dugdha paan In The Management Of Nidranash/Insomnia |
2 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Study Nidranash and Insomnia And To Study Mode Of Action Of Go-dugdha and Mahish dugdha paan in adults. |
60 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/09/2025 |
| 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="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
|
In today’s era contemporary therapeutic variety of sedative are prescribed for managing insomnia. These tranquilizers initially give substantial aid in insomnia but permanent and extensive use may stimulate various lethal effects including drug addiction. Various studies have noted in year 2016, insomnia to be quite a common condition with symptoms present in about 33-50% of the adult population. The prevalence, however, ranges from 10 to 15% among the general population, with higher rates seen among divorced, separated, or widowed people, older ages, female gender, white population, and in the presence of co-morbid medical or psychiatric illness. About 30% of all adults complain of occasional insomnia and 10% of chronic insomnia, of whom 40% may have a psychiatric illness. Despite these high prevalence rates, evidence suggests that insomnia is mostly under-recognized, under-diagnosed, and under-treated, with the condition continuing to remain persistent in 50-85% of individuals over follow-up intervals of one to several years. Insomnia patients are more likely to visit hospitals and physicians, have increased absenteeism, make errors or have accidents at work, and have more fatal road accidents. There is also an increased risk for depression, anxiety, substance use, suicide, and possible immune dysfunction. Hence rather than using sedative on large scale, Go-Dugdha and Mahish Dugdha which is already described in classical text can be preferred for treating "nidranash". If it’s efficacy is proved through this study, this will be beneficial for larger population. |