| CTRI Number |
CTRI/2022/04/042117 [Registered on: 25/04/2022] Trial Registered Prospectively |
| Last Modified On: |
22/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to find out the effect of shirodhara with balaswagandhadi taila,rasayan churna vati and lifestyle modification in post menopausal women |
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Scientific Title of Study
|
Randomized study to evaluate the role of lifestyle modificatiion,rasayan churna vati and shirodhara in postmenopausal women - An open label comparitive clinical trial |
| Trial Acronym |
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|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Athira k |
| Designation |
PG scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no 405,4 th floor, Academic block, All India Institue of Ayurveda, Goutampuri, Saritavihar,New Delhi
South
DELHI
110076
India |
| Phone |
9947150302 |
| Fax |
|
| Email |
athirachandran1442@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamini Dhiman |
| Designation |
Associate professor |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
room no 402, 4 th floor,Academic block, All India Institue of Ayurveda, Goutampuri, Saritavihar,New Delhi
South
DELHI
110076
India |
| Phone |
8920900968 |
| Fax |
|
| Email |
kd44ayu@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamini Dhiman |
| Designation |
Associate professor |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
room no 402, 4 th floor,Academic block, All India Institue of Ayurveda, Goutampuri, Saritavihar,New Delhi
South
DELHI
110076
India |
| Phone |
8920900968 |
| Fax |
|
| Email |
kd44ayu@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| all india institute of ayurveda |
|
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Primary Sponsor
|
| Name |
All India Institute Of Ayurveda |
| Address |
All India Institute Of Ayurveda,Goutampuri,Saritavihar,New Delhi,110076 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Athira k |
All India Institute Of Ayurveda |
All india institute of ayurveda,Goutamuri,saritavihar,New Delhi,110076
South
DELHI |
9947150302
athirachandran1442@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC - AIIA |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (2) ICD-10 Condition:N952||Postmenopausal atrophic vaginitis. Ayurveda Condition: rajonirvrtti, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: rasayanchurnavati, Reference: ashtangahrdayam uttarastana, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - | | 2 | Comparator Arm | Procedure | - | shirodhara | (Procedure Reference: sahasrayoga, Procedure details: shirodhara with balaswagandhadi taila for a duration of 21 days schedule with 5 days shirodhara session of 30 minutes with 3 days gap in beyween )
(1) Medicine Name: rasayan churnavati, Reference: ashtangahrdaya uttarastana, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 3(g), Frequency: bd, Duration: 21 Days | | 3 | Comparator Arm | Lifestyle | - | - | Dinacarya: according to prakriti, Ritucarya: according to ritu, Acara Rasayana:, Other:, Pathya/Apathya:no, Pathya:, Apathya: |
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Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1. women who have cessation of menstruation for 1 year or more
2. women fulfilling diagnostic criteria of menopausal syndrome
3. postmenopausal women with symptoms of menopausal syndrome, who are willing to prticipate in the study |
|
| ExclusionCriteria |
| Details |
1. Postmenopausal women who had previos exposure to therapieseg; yoga and panchakarma procedures taken within 3 months.
2. postmenopausal women who are undergoing hormonal replacement therapy
3. patients suffering from any major illness, eg; cancer, diabetis mellitus,cardiac disorerstuberculosis etc
4. Patients having surgical menopause |
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Impovement in symptoms will be assessed using kupperman index and menopause rating scale |
21 days |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| to see change in quality of life of postmenopausal women |
2 months intervention and 2 months follow up |
|
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Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
29/04/2022 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
nil |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Menopause is one of the most important phases of life of a woman. It is defined as permanent cessation of menstruation at the end of reproductive life due to loss of ovarian follicular activity1. It is a natural process that happens to every woman as she grows older and not a medical problem, disease or illness, even though it may appear so2. CLASSICAL According to ayurvedic classics, while describing physiology of menstruation, it is mentioned that complete cessation of menstruation occurs at the age of 50 years. 6 By this time women in reproductive phase of life having pitta predominance terminates into the vata phase of life.7It is also mentioned as a kshaya stage of life due to aging process. Kshaya of dhathus, mainly rasa dhathu will ultimately leads to raja kshaya which is considered to be the byproduct of the former. Raja itself is a physiological entity which is having swabhava of degradation and ultimately manifests as rajonirvritti. Diminition of dhathus will manifests in woman as various anatomical and psychological symptoms and they are described as menopausal syndrome in modern medical science. INVESTIGATIONS A. Routine Blood investigations including CBC, TFT, lipid profile , LFT , KFT , Blood sugar B. Urine for routine and microscopic examination C. Hormonal essay for FSH and LH D. USG 16 GROUPING AND DRUG DELIVERY REGIME S.NO | Group | Description | Dose & Duration | 1 | Group A | Lifestyle modifications. |
| 2 | Group B | 1.Rasayan churna vati 2.Lifestyle modifications | 3 tablets twice a day with lukewarm water , daily after meals for 21 days | 3 | Group C | 1.Abhyanga(Tila taila -15 minutes),swedana(Sarawanga swedana by Dashamool kashaya for 5 -7 minutes) Shirodhara with Balaswhagandhadi taila. 2.Rasayan churna vati 3.Lifestyle modifications | 1) 21 days schedule with 5 days Shirodhara sessions of 30 minutes with 3 days break in between will be advocated (i. e 3 cycles of 5 days each). 2) 3 tablets twice a day with lukewarm water , daily after meals for 21 days. |
Lifesstyle modification as per the previous study will be advised to patient and also relatives and will make sure they are doing it by regular follow up. FOLLOW UP At the interval of 2 weeks for 2 months after completion of the treatment. 17 WITHDRAWAL CRITERIA 1) If patient is unwilling to continue the selective procedure. 2) If patient is allergic / sensitive to selective procedures.
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