| CTRI Number |
CTRI/2026/03/106268 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of soma churna along with milk on improving sleep in people with long term sleep problems. |
|
Scientific Title of Study
|
A single-arm, open-label clinical trial on the effect of soma churna along with milk in 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 Hridya C P |
| Designation |
P G Scholar, Department of Kayachikitsa |
| Affiliation |
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital |
| Address |
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital, Cheruthuruthy, Thrissur, Thrissur, Kerala
Cheruthuruthy, Thrissur, Thrissur, Kerala
Thrissur
KERALA
679531
India |
| Phone |
09349030411 |
| Fax |
|
| Email |
hridyacp07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ratheesh P |
| Designation |
HOD and Professor, Department of Kayachikitsa |
| Affiliation |
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital |
| Address |
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital, Cheruthuruthy, Thrissur, Thrissur, Kerala
Cheruthuruthy, Thrissur, Thrissur, Kerala
Thrissur
KERALA
679531
India |
| Phone |
09349030411 |
| Fax |
|
| Email |
drrpnair07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ratheesh P |
| Designation |
HOD and Professor, Department of Kayachikitsa |
| Affiliation |
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital |
| Address |
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital, Cheruthuruthy, Thrissur, Thrissur, Kerala
Cheruthuruthy, Thrissur, Thrissur, Kerala
KERALA
679531
India |
| Phone |
09349030411 |
| Fax |
|
| Email |
drrpnair07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital, Cheruthuruthy, Thrissur, Thrissur, Kerala, 679531 |
|
|
Primary Sponsor
|
| Name |
Dr Hridya C P |
| Address |
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital, Cheruthuruthy, Thrissur, Thrissur, Kerala, 679531 |
| 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 Hridya C P |
Poomulli Neelakandan Namboodiripad Memorial Medical College and Hospital |
Room No G01
Department of Kayachikitsa
PNNM Ayurveda Medical College Thrissur, Kerala, 679531
Thrissur
KERALA |
09349030411
hridyacp07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PNNM Ayurveda Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F510||Insomnia not due to a substance orknown physiological condition. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: SOMA CHURNA, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: MILK), Additional Information: Soma churna the trial drug is an anubhootha yoga
(traditional formulation developed through practical experience) |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age between 30 to 60 years. Fulfilling diagnostic criteria. With mild to moderate insomnia. Irrespective of the gender. Willing to give informed consent. |
|
| ExclusionCriteria |
| Details |
Persons who are under medication for insomnia. Suffering from psychiatric disorders. Suffering from hypotension. Those with other systemic illness. Pregnant and lactating women. Those who are engaged in rotating shift schedules. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in the score of -
a) Insomnia Severity Index score.
b) Pittsburgh Sleep Quality Index.
|
Assessment on 1st day, 31st day and 61st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment on quality of sleep in chronic insomnia using PSQI. |
Assessment on 1st day, 31st day and 61st day |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
24/03/2026 |
| 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="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
|
This single-arm open labelled clinical study aims to evaluate the effect of Soma churna along with milk in reducing the symptoms of
chronic insomnia and assess the effect trial drug on quality of sleep in participants
with chronic insomnia. A total of 22 participants fulfilling the inclusion and exclusion criteria will be recruited consecutively from the OPD of PNNM Ayurveda Medical College and Hospital, Cheruthuruthy. Soma churna will be administered orally at a dose of 12gm during bed time after food for 30 days consecutively. Subjective assessment will be done on 1st day, 31st day and 61st day. Data will be analyzed using paired t-test or Wilcoxon signed-rank test. This study facilitates the scientific validation of traditional knowledge, thereby advancing integrative
healthcare approaches that support patients seeking alternatives to addictive sedatives and
tranquilizers widely prescribed for insomnia. |