| CTRI Number |
CTRI/2025/04/084349 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Shankhapushpi and Jatamansi siddha taila Shirodhara on Anidra |
|
Scientific Title of Study
|
RANDOMIZED CONTROLLED TRIAL OF SHANKHAPUSHPI AND JATAMANSI SIDDHA TAILA SHIRODHARA IN ANIDRA |
| 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 Anuradha Kishor Ingale |
| Designation |
PG Scholar |
| Affiliation |
PMTs Ayurveda College, Shevgaon |
| Address |
OPD NO. 108 PANCHAKARMA DEPARTMENT, SHRI EKNATH AYURVED RUGNALAYA, PMTs Ayurveda College, Shevgaon Akhegaon road, Tal. Shevgaon, Dist. Ahmednagar, Maharashtra
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
8237371907 |
| Fax |
|
| Email |
anuingale812@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Gandhi |
| Designation |
Professor and HOD |
| Affiliation |
PMTs Ayurveda College, Shevgaon |
| Address |
OPD NO. 108 PANCHAKARMA DEPARTMENT, SHRI EKNATH AYURVED RUGNALAYA, PMTs Ayurveda College, Shevgaon Akhegaon road, Tal. Shevgaon, Dist. Ahmednagar, Maharashtra
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9423389866 |
| Fax |
|
| Email |
arihantsai977@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Gandhi |
| Designation |
Professor and HOD |
| Affiliation |
PMTs Ayurveda College, Shevgaon |
| Address |
OPD NO. 108 PANCHAKARMA DEPARTMENT, SHRI EKNATH AYURVED RUGNALAYA, PMTs Ayurveda College, Shevgaon Akhegaon road, Tal. Shevgaon, Dist. Ahmednagar, Maharashtra
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
09423389866 |
| Fax |
|
| Email |
arihantsai977@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO. 108 PANCHAKARMA DEPARTMENT, SHRI EKNATH AYURVED RUGNALAYA, PMTs Ayurveda College, Shevgaon Akhegaon road, Tal. Shevgaon, Dist. Ahmednagar, Maharashtra Ahmadnagar MAHARASHTRA - 414502 India |
|
|
Primary Sponsor
|
| Name |
PMTs Ayurveda College, Shevgaon |
| Address |
Shevgaon , Tal. Shevgaon Dist. Ahmednagar Maharashtra 414502 |
| 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 |
| Dr Anuradha Kishor Ingale |
PMTs Ayurveda College, Shevgaon |
PANCHAKARMA DEPARTMENT, OPD NO. 108 SHRI EKNATH AYURVED RUGNALAYA, PMTs Ayurveda College, Shevgaon Akhegaon road, Tal. Shevgaon, Dist. Ahmednagar, Maharashtra
Ahmadnagar
MAHARASHTRA |
8237371907
anuingale812@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 | Intervention Arm | Procedure | - | SiraHsekaH, शिरःसेकः | (Procedure Reference: Sahastrayoga Dharakalpa 13, Procedure details: Shirodhara is performed with the patient lying in a supine position with the head & neck supported with a roll of towel or a pillow
Cotton pads are placed over the eyes to protect them from the oil during the procedure & Dharapatra will be brought at 4 Angula height above his head
Shankhapushpi & Jatamansi siddha taila will be kept in the vessel & be poured continuously on the forehead of the patient
A mild oscillation will be given to maintain the flow all over the forehead & this liquid gets collected in a vessel that is kept below the table when the liquid in the vessel gets emptied then it is replaced by a lower vessel
Oil will be reheated & poured into Dharapatra
Shirodhara duration will be 45 minutes
After completing the Shirodhara procedure the oil from the head will be removed by a piece of cloth & Rasnadi churna will be applied over the head
This procedure is done on 40 patients who are included in Group A for Intervention for 7 days & then patients symptoms are observed on 0 7 & 14 day)
| | 2 | Comparator Arm | Procedure | - | Siro~aBya~ggaH, शिरोरऽभ्यंग | (Procedure Reference: Charak samhita Sutrasthana 5, Procedure details: Shiroabhyanga is applying oil to head & lightly massaging
Oil with optimum temperature will be applied to head first in the anterior frontanelle & then whole scalp
Shiroabhyanga duration will be 30 minutes
After completing shiroabhyanga oil from head will be removed by piece of cloth & Rasnadi churna will be applied over head
This procedure is done on 40 patients in the morning which are included in Group B for Comparator for 7 days & then patients symptoms are observed on 0 7 & 14 day)
|
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|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with signs and symptoms of Anidra , As per DSM-5 Criteria for Insomnia Diagnosis and as per PSQI scale.
Irrespective of their sex, race & religion and economic status barrier.
|
|
| ExclusionCriteria |
| Details |
Participants suffering from any psychiatric disorder or any major medical illness requiring significant care.
Pregnant women.
Patient undergone Shirodhara procedure prior to screening.
Any known allergy to the treatment components.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Shankhapushpi and Jatamansi siddha taila Shirodhara in Anidra.
Is there any reduction in symptoms or frequency of symptoms of ANIDRA (insomnia) that will be assessed after 14 days. |
7 day treatment with 3 follow up 0, 7, and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To review Anidra (Insomnia) in detail from Ayurveda and modern perspective.
To evaluate the effect of Tila taila Shiroabhyanga in Anidra (Insomnia).
To compare the effect of Shirodhara with Shankhapushpi and Jatamansi siddha taila and Shirobhyanga with Tila taila in Anidra.
To observe adverse effect of drugs during the procedure. |
7 day treatment with 3 follow up 0, 7, and 14th day |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
21/04/2025 |
| 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
|
The prevalence of insomnia is variable depending on the parameters selected. Various studies worldwide have shown the prevalence of insomnia in 10% -30% of the population, some even as high as 50% -60%. In US adults 1 in 5 struggle to sleep every single night. In India, in a study among 2475 adult subjects of 30-60 years, it was found that 28.1% of the subjects reported having complaints suggestive of disorders of initiation and maintenance of sleep. It is important to note that this is not a direct causal relationship between sleep duration and increased mortality, as multiple behavioral and co-morbid factors (age, gender, obesity, diabetes mellitus, hypertension, and smoking) interact, with possible cumulative effects leading to the observed increases in mortality. The value of getting enough sleep is acknowledged on a global scale. That’s why the significance of sleep to health status deserves particular and earnest attention. When the treatment of insomnia is concerned, contemporary medicine includes antidepressants which have adverse effects, like nausea, increased appetite and weight gain, further increase of anxiety and dizziness. Allopathic hypnotic drugs are useful for the short-term treatment of insomnia which is due to acute stage. Long-term uses of certain classes of sedatives cause physical dependence and withdrawal symptoms also have several side effects. Complaints of insomnia tend to be persistent or recurrent over time. Thus, it seems that patients with chronic insomnia need some form of treatment.
So in search of a potent therapy to manage Anidra, we can consider medicines mentioned in our classics. Shirodhara is the procedure that tends to reduce symptoms of Anidra mentioned in Dharakalpa. 13/10-18 At the same time, Shankhapushpi and Jatamansi are medhya dravyas and these drugs show vata shaman properties as well as an increase in tama guna mentioned in Bhavprakash, Kaiyadeva, Dhanvantari and Raj Nighantu. So, this study is carried out to find the effect of this dravya as a Shirodhara tail in Anidra. |