| CTRI Number |
CTRI/2025/08/093547 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To check how well Saraswatharishta and Drakshasava, along with foot massage (Pada Abhyanga), work in improving sleep in people who have primary insomnia (trouble sleeping without any other disease) |
|
Scientific Title of Study
|
An open label randomized comparative clinical study on the efficacy of Saraswatharishta and Drakshasava along with Pada Abhyanga in Anidra W.S.R to Primary 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 Nisha C |
| Designation |
PG scholar |
| Affiliation |
Rajiv gandhi university |
| Address |
Room number 2 First Floor Department of Kayachikitsa Dhanvantari Ayurveda College and Hospital and PG Research Center Siddapura
Room number 2 First Floor Department of Kayachikitsa Dhanvantari Ayurveda Medical College Hospital and PG research centre siddapura
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
9740535998 |
| Fax |
|
| Email |
nishachippar3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa Bhat |
| Designation |
Professor and HOD |
| Affiliation |
Rajiv gandhi university |
| Address |
Room number 2 First Floor Department of Kayachikitsa Dhanvantari Ayurveda College and Hospital and PG Research Center Siddapura
Room number 2 First Floor Department of Kayachikitsa Dhanvantari Ayurveda College and Hospital and PG Research Center Siddapura
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
9845301333 |
| Fax |
|
| Email |
ayurroopa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha C |
| Designation |
PG scholar |
| Affiliation |
Rajiv gandhi university |
| Address |
Room number 2 First Floor Department of Kayachikitsa Dhanvantari Ayurveda College and Hospital and PG Research Center Siddapura
Room number 2 First Floor Department of Kayachikitsa Dhanvantari Ayurveda College and Hospital and PG Research Center Siddapura
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
9740535998 |
| Fax |
|
| Email |
nishachippar3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa Dhanvantari Ayurveda Medical College Hospital siddapura |
|
|
Primary Sponsor
|
| Name |
Dr Nisha C |
| Address |
Dhanvantari Ayurveda College Hospital and PG Research Centre Siddapur (Uttara Kannada District) Karnataka 581335 India |
| 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 Nisha C |
Dhanvanthari ayurveda medical college and hospital |
OPD and IPD Department of Kayachikitsa Dhanvanthari ayurveda college hospital and PG research centre siddapura 581355
Uttara Kannada
KARNATAKA |
9740535998
nishachippar3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dhanvantari Ayurveda College, Hospital and Research Centre Siddapur Uttara kannada Karnataka 581335 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G||Mental Health. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Saraswatharishta , Reference: Bhaishajya rathnavali , Route: Oral, Dosage Form: Arishta, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: Along with padaabhyanga with tila taila | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Drakshasava , Reference: Bhaishajya rathnavali , Route: Oral, Dosage Form: Asava, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: Along with padaabhyanga with tila taila |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who gave written consent for Clinical trial.
2. Patients of either sex in the age group of 18-60 years.
3.Subjects of either of the gender, irrespective of socio-economic status.
4.Patients presenting with any two or more Lakshana of Nidranasha (Angamarda, Shirogaurava,
Jadyata, , Bhrama, Jrumbha, Glani, Apakti).
5. Diagnosed case of Primary Insomnia. |
|
| ExclusionCriteria |
| Details |
1. Age less than 18 and more than 60 years.
2. Pregnant and lactating women.
3. Secondary insomnia to mental disorders.
4. Subjects with secondary causes like breathing related sleep disorder, psychiatric related sleep
disorder.
6. Subjects suffering from Diabetes mellitus. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in clinical symptoms subjective and objective - Angamardha, Shirogaurava,Jrumbha,Jadya ,Glani,Bhrama,Tandra,Apakti. |
Patients will be assessed on 0th day,15th and final assessment on 31stday. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in overal signs & symptoms of anidra improvement in quality of sleep |
Patients will be assessed on 0th day,15th,final assessment on 31st day. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
08/09/2025 |
| 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="0"
Months="1"
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 study is a randomized open-label clinical trial evaluating the efficacy of two Ayurvedic formulations, Saraswatharishta and Drakshasava, in combination with Pada Abhyanga (foot massage with sesame oil), in managing Anidra (primary insomnia). Sleep being a critical aspect of health, its loss is considered a Vata-dominant disorder in Ayurveda. Anidra has been equated with primary insomnia, a widespread condition affecting up to 20% of the global population. Classical texts emphasize Nidra as one of the pillars of life. The study involves 40 patients aged 18–60 years, divided equally into two groups. One group receives Saraswatharishta and the other Drakshasava, both along with daily Pada Abhyanga for 30 days. Effectiveness is assessed using the Athens Insomnia Scale based on ICD-10 criteria. The hypothesis compares the relative effectiveness of both treatments. Drug formulations are prepared as per classical Ayurvedic procedures. The study aims to establish a safe, effective, and holistic Ayurvedic approach to treating insomnia, potentially contributing to standard clinical guidelines. Ethical approval has been obtained, and all parameters including adverse reactions, compliance, and follow-up are methodically planned. |