| CTRI Number |
CTRI/2022/09/045151 [Registered on: 01/09/2022] Trial Registered Prospectively |
| Last Modified On: |
31/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the effect of application of Ksheera bala oil on head and foot massage for sleeplessness in Menopausal women |
|
Scientific Title of Study
|
An Open label Single-arm study to Evaluate the Effect of Siropicu and Padabhyanga with Ksirabala taila in the management of Insomnia in Menopausal Women |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parvathy B |
| Designation |
Second year PG Scholar |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department Of Stri Roga And Prasuti Tantra(Gynaecology and
Obstetrics)
Amrita School of Ayurveda
Amrita Vishwa Vidyapeetham,
Amritapuri clappana P.O.
Kollam
KERALA
690525
India |
| Phone |
7025060023 |
| Fax |
|
| Email |
amayp3pts20027@ay.amrita.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shaithya Raj |
| Designation |
Associate Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department Of Stri Roga And Prasuti Tantra(Gynaecology and
Obstetrics)
Amrita School of Ayurveda
Amrita Vishwa Vidyapeetham,
Amritapuri Clappana P.O.
Kollam
KERALA
690525
India |
| Phone |
9495434862 |
| Fax |
|
| Email |
shaithyaraj@ay.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parvathy B |
| Designation |
Second year PG Scholar |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department Of Stri Roga And Prasuti Tantra(Gynaecology and
Obstetrics)
Amrita School of Ayurveda
Amrita Vishwa Vidyapeetham,
Amritapuri clappana P.O.
Kollam
KERALA
690525
India |
| Phone |
7025060023 |
| Fax |
|
| Email |
amayp3pts20027@ay.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Amrita School of Ayurveda
Amrita Vishwa Vidyapeetham,
Amritapuri, Clappana P.O.
Kerala, India – 690 525. |
|
|
Primary Sponsor
|
| Name |
Dr Parvathy B |
| Address |
Amrita School of Ayurveda
Amrita Vishwa Vidyapeetham,
Amritapuri, Clappana P.O.
Kerala, India – 690 525. |
| 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 Parvathy B |
Amrita Ayurveda Hospital |
(OPD NO-5) and IPD of
Department of Stri
Roga And Prasuti
Tantra (Gynaecology
and Obstetrics), Amrita
School of Ayurveda
Amritapuri Amrita
Viswha Vidyapeetham
India
Kollam
KERALA
Kollam
KERALA |
7025060023
amayp3pts20027@ay.amrita.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Amrita Institute of Medical Science, Kochi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N951||Menopausal and female climactericstates. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | SiraHpicuH | (Procedure Reference: (Su. Sa. 4/43), Procedure details: After taking informed consent, the procedure of siropicu and pada abhyanga will be explained and proper training will be given to the patient and bystander. The patient will also receive a pamphlet and video demonstrating the detailed procedure of siropicu and pada abhyanga. The patient is advised to do siropicu 1 hour before sleep with a duration of 30 minutes for 7 days and after the procedure, wipe it clearly with a dry cloth. Patients will be advised to report on the 8th day, the assessment )
(1) Medicine Name: Ksirabala taila, Reference: (Sahasrayoga taila prakarana), Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | EkA~gga | (Procedure Reference: (Su. Ci. 24/70), Procedure details: After taking informed consent, the procedure of Siropicu and Padabhyanga will be explained and proper training will be given to the patient and bystander. A pamphlet and video demonstrating the detailed procedure of Siropicu and Padabhyanga will also be given to the patient.Patient is advised to do Padabhyanga on each foot for a minimum of 5 minutes twice daily for 15 days and advised to take rest for 10 minutes after the procedure and wipe it clearly with a dry cloth.Patient will be advised to )
(1) Medicine Name: Ksirabala taila, Reference: (Sahsrayoga taila prakarana), Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Amenorrhea (greater than or equal to 12 consecutive months)
2. Age group (40 – 60 yrs)
3. Insomnia severity index score (greater than or equal to 8)
|
|
| ExclusionCriteria |
| Details |
1. Hypertension
2. Chronic illness where Insomnia is seen as a complication ( Parkinson’s disease, Epilepsy)
3. Any known case of Malignancy
4. Anxiety and Depression (Hospital Anxiety and Depression Scale score greater than 7)
5. Women taking any medication influencing sleep
6. Known case of other Sleep disorders such as Restless leg syndrome and obstructive sleep apnea
7. Known case of Sinusitis
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Severity of Sleep: Insomnia severity index.
2. Quality of sleep: Pitts burg sleep quality index (PSQI scale)
|
At base line 1st Day (D1)
8th Day (D8)
16th Day (D16) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
12/09/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [amayp3pts20027@ay.amrita.edu].
- For how long will this data be available start date provided 08-03-2024 and end date provided 08-10-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
BACKGROUND Insomnia is characterized by long sleep latency, frequent awakening or prolonged period of wakefulness during the sleep period, or even frequent transient arousal. Insomnia that occurs for at least three nights a week for three consecutive months is considered chronic and results in social, occupational, and behavioral distress. Women complain more frequently of insomnia than men and insomnia increases with age. The prevalence of sleep disturbances in Postmenopausal women is about 28% - 63%. Menopausal Insomnia is associated with multiple adverse effects on quality of life, decreased work productivity, and increased healthcare utilization, and also with a higher prevalence of anxiety, depression, and cardiovascular diseases. Shira is considered as uttamanga, the place where the prana, controls all the activities and all the indriya’s are located. Shiro Pichu is one among the Murdhini taila. Murdhini taila is a chikitsa for Nidranasha. Padaabhyanga is considered as Nidrakrit ,Maruta Upashamana and Ksheerabala taila is Rasayana Mukyatama, Jeevana, Brihmana, Indriyaprasadana and Sukra Asruk dosha nashana effective in curing all 80 types of vata rogas and can be used as Pana, Basti, Nasya and Abhyanga.
RATIONALE AND NEED FOR STUDY Menopausal women show an increased prevalence of Insomnia for years after diagnosis and treatment. Neglected Insomnia in postmenopausal women will lead to impairment in their work or at home and thus decrease quality of life, memory problems, increase anxiety, depression, and reduced capacity in carrying out day-to-day activities, and also worsen the associated menopausal symptoms. Treatment protocols for Insomnia are mainly Hypnotic drugs and cognitive behavioral therapy. Prolonged use of Hypnotic drugs may result in drug dependence, sleepiness, hangovers in the morning, sleep impairment after discontinuation, and ultimately not cure Insomnia. In this scenario, it becomes more significant to find out the effect of other alternative therapies in managing this condition. Already proven methods are combined and incorporated into the management of Menopausal Insomnia to get better results. In Ayurveda Padaabhyanga and Shiropichu are advised as management for Nidranasha. Ksheerabala taila, the ingredients Ksheera is Jeevaniya, Nidrajanana, Bala (Sida cordifolia) and tila taila has Vata hara properties. In this study, an attempt is made to know the efficacy of Padaabhyanga and Shiropichu with Ksheerabala taila in the management of Menopausal Insomnia.
METHODOLOGY 30 patients attending Streeroga & Prasuti Tantra OPD & IPD of Amrita Ayurveda Hospital fulfilling the inclusion criteria will be recruited for the study. After taking informed consent, the procedure of shiro pichu and pada abhyanga will be explained and proper training will be given to the patient and bystander. A Pamphlet and video demonstrating the detailed procedure of shiro pichu and pada abhyanga will be also given to the patient. The patient is advised to do, Shiro pichu 1 hour before sleep with a duration of 30 minutes after that patient is advised to rest for 10 minutes after the procedure. The Duration of Shiropichu is 7 days. Padaabhyanga should be done on each foot for 15 minutes twice daily and advised to take rest for 10 minutes after the procedure. The duration of pada abhyanga is 15 days. Assessment will be done on the 1st Day (D1) - On the day of recruitment, on the 8th Day (D8) - After the completion of Shiro Pichu, and 16th Day (D16) -After the completion of Padaabhyanga. The patient will be advised to report on the 8 th day, the assessment will be done, and also advised to stop Shiropichu and continue Padaabhyanga for 8 days. Assessment criteria used in the study are the Pittsburgh sleep quality Index and Insomnia severity index. •
DURATION OF STUDY: 15 days |