| CTRI Number |
CTRI/2025/09/095493 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Nidrakar Churna and Shiropichu with Ksheerbala Taila in improving sleep among patients with Insomnia |
|
Scientific Title of Study
|
Clinical evaluation of Nidrakar Churna and Shiropichu with Ksheerbala Taila in Anidra (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 |
KANIKA |
| Designation |
POST GRADUATE SCHOLAR |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD no. 13, 14, Department of Kayachikitsa, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Delhi-Haridwar National Highway 58, Haridwar, Uttarakhand, India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9813642311 |
| Fax |
|
| Email |
kanikagoyal1231@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHUBHAM SADH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD no. 13, 14, Department of Kayachikitsa, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Delhi-Haridwar National Highway 58, Haridwar, Uttarakhand, India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8792429267 |
| Fax |
|
| Email |
shubhamsadh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHUBHAM SADH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD no. 13, 14, Department of Kayachikitsa, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Delhi-Haridwar National Highway 58, Haridwar, Uttarakhand, India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8792429267 |
| Fax |
|
| Email |
shubhamsadh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Delhi-Haridwar National Highway 58, Haridwar, Uttarakhand, India |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Delhi-Haridwar National Highway 58, Haridwar, Uttarakhand, India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| KANIKA |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
OPD no. 13, 14, Department of Kayachikitsa, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Delhi-Haridwar National Highway 58, Haridwar, Uttarakhand, India
Hardwar
UTTARANCHAL |
9813642311
kanikagoyal1231@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
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 | Classical | | (1) Medicine Name: Nidrakar Churna, Reference: Mishra, S.N. (2016). Bhaiṣajya Ratnavali, Siddhipradha Hindi Vyakhya (21/10, 491). Varanasi: Chaukhamba Surbharti Prakashan., Route: Oral, Dosage Form: Churna/ Powder, Dose: 0.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Guda), Additional Information: | | 2 | Intervention Arm | Procedure | - | SiraHpicuH, शिरःपिचुः | (Procedure Reference: Sushruta Samhita Sharira Sthana 4/42, Procedure details: Application of lukewarm Ksheerbala Taila 70-80 ml soaked Pichu on Brahmarandhra for 30 minutes in early morning for 7 days)
(1) Medicine Name: Ksheerbala Taila, Reference: Department of Indian Systems of Medicine and Homeopathy. (2003). The Ayurvedic Formulatory of India (2nd ed., text rev., part 1, section 8, p. 132). Delhi: The Controller of Publications, Civil Lines., Route: Topical, Dosage Form: Taila, Dose: 70(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having classical symptoms of Anidra such as Tandra, Angamarda, Jrumbha, Arati, Klama, Shirashoola and Akshigaurava
2. Patients fulfilling DSM V Criteria for Insomnia
3. Both new and previously treated cases will be included
4. Patients aged between 18 and 70 years
5. Patients of either gender irrespective of their race, occupation, religion and socio economic status
6. Patients who will be capable and willing to adhere to all study related instructions, attend all scheduled visits and sign the consent form
|
|
| ExclusionCriteria |
| Details |
1. Physiological conditions like pregnancy, lactation and puerperal stage
2. History of any acute systemic pathological illness such as fever in the preceding one month
3. Patients with insomnia comorbid with other medical conditions
4. Patients with impaired Renal, Hepatic or Cardiac function
5. Patients having drug or alcohol dependency
6. Exaggeration of previous psychiatric illness such as major depression and mania
7. Use of hypnotics or other therapies for insomnia within the past 4 weeks
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improvement in Insomnia Severity Index (ISI) score
2. Improvement in Ayurvedic symptom grading (Tandra, Akshigaurava, Shirashoola, Angamarda, Arati, Klama, Jrumbha) |
Day 1, Day 30, Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety and tolerability of the intervention |
Day 1, Day 30, Day 60 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
08/10/2025 |
| 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="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 is an open-label, single-arm clinical study to evaluate
the efficacy of Nidrakar Churna (oral) and Shiropichu with Ksheerbala Taila in
the management of Anidra (Insomnia). A total of 60 patients fulfilling DSM-5
criteria for insomnia will be enrolled from the OPD of Kayachikitsa, Patanjali
Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar. The intervention will
be administered for 60 days, with assessments at day 1, day 30, and day 60.
Primary outcomes will be measured using classical Ayurvedic parameters and the
Insomnia Severity Index (ISI) scale. The study aims to provide an effective and
safe Ayurvedic therapeutic approach for insomnia.
|