| CTRI Number |
CTRI/2024/04/066069 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Kadamb Taila- An ayurvedic medicated oil, in improving quality of sleep. |
|
Scientific Title of Study
|
An Assessment of Efficacy of Kadamb Taila in sleep pattern and quality : Two armed, Randomized, Single Blind, Active Controlled Prospective Clinical Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishwaraj Mandar Borkar |
| Designation |
UG Student |
| Affiliation |
RA Podar Medical College (Ayu) |
| Address |
RA Podar Ayurvedic Medical College, Worli, Mumbai,
Mumbai
MAHARASHTRA
400018
India |
| Phone |
7738246069 |
| Fax |
|
| Email |
vishwarajborkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhuri Pachghare |
| Designation |
Assistant Professor |
| Affiliation |
RA Podar Medical College (Ayu) |
| Address |
Depart of Samhita Siddhant, RA Podar Ayurvedic Medical College, Dr Annie Besant Road,Worli, Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9869122970 |
| Fax |
|
| Email |
drmap1965@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vishwaraj Mandar Borkar |
| Designation |
Undergraduate Student |
| Affiliation |
RA Podar Medical College (Ayu) |
| Address |
RA Podar Medical College (Ayu), Dr Annie Besant Road, Worli, Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
7738246069 |
| Fax |
|
| Email |
vishwarajborkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| MA Podar Hospital, Worli, Mumbai, 400018 |
|
|
Primary Sponsor
|
| Name |
RA Podar Medical College (Ayu) |
| Address |
Dr Annie Besant Road, Worli, Mumbai, 400018 |
| Type of Sponsor |
Government 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 |
| Vishwaraj Mandar Borkar |
MA Podar Hospital |
Department of Panchakarma, MA Podar Hospital, Dr Annie Besant Road, Worli, Mumbai, 400018
Mumbai
MAHARASHTRA |
7738246069
vishwarajborkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, R A Podar Medical College (Ayu) & M.A. Podar Hospital Worli, Mumbai, Maharashtra |
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 | Drug | Other than Classical | | (1) Medicine Name: Kadamb Taila, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 10(drops), Frequency: hs, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: 10 drops LA on top of the head followed by light massage. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Til taila, Reference: Cha su 13.12, Route: Topical, Dosage Form: Taila, Dose: 10(drops), Frequency: hs, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -), Additional Information: 10 drops on top of the head before sleeping |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having problems in sleeping/ having disturbed sleep
Patients showing any one symptom in past one month of nidranaash- angamard, shirogaurav, jrumbhika, jadya, glaani, bhrama, apakti, tandra |
|
| ExclusionCriteria |
| Details |
Patients having shifting/ night duty.
Patients suffering from life threatening chronic/ acute illness/psychosomatic disorder.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. There is reduction in PSS-10 scores indicating reduced stress levels.
2. There is an increase in PSQI scores indicating improved quality of sleep. |
Day 1 and Day 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assesment of stress levels and difference in sleep patterns if any |
Day 1 and Day 15 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| Date of Study Completion (India) |
31/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/05/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Disturbed sleep is one of the biggest problem in todays world. Mainly sleep is disturbed due to increase in the overall amount of stress among the individuals. Hence it is necessary to reduce the levels of stress among individuals and increase the quality of sleep. Kadamb dravya is tridoshaghna and included in Vedanasthapana gana in charak samhita. Also there is a reference pof sushrut samhita which says murdha taila dharan is helpful in getting quality sleep. Hence Kadamb taila is prepared from Panchang of Kadamba. Madhyam paak is prepared. Proper authentication and standardisatrion is done of the raw naterial and of the finished product. For an active control til taila is used. The study is divided into 2 arms - Intervention arm- Kadamb Taila Comparstor arm- Til taila. The study is single blind(Participant blinded). Randomization is done using compiuter software. 30 sample size is taken from each arm arm making it 60. The volunteers are asked to apply 10 drops of oil on top of head before sleep for a period of 15 days. Sleep data which contains time of sleep is collected from the patients. Stress level is calculayed from PSS10 scores. Sleep quality is calculated from PSQI. After 15 days follow up is taken. The PSS10 and PSQI are calculated and chages are noted, Stastical analysis is done and appropriate conclusion is drawn. |