| CTRI Number |
CTRI/2024/08/072919 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of
Artavajanan property of JVAS(Jyotishmati,Vacha,Asan,Swarjika kshar)compound in Amenorrhoea |
|
Scientific Title of Study
|
Clinical evaluation of Artava janana property of Jyotishmati,Vacha,Asan,Swarjika kshar (JVAS)compound in Rajonasha |
| 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 Sarita Saroj |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Science BHU |
| Address |
Department of Prasuti Tantra
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi UTTAR PRADESH 221005 India |
| Phone |
9598881924 |
| Fax |
|
| Email |
saritaghazipur94@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shikha Singh |
| Designation |
Assistant Professor |
| Affiliation |
IMS BHU |
| Address |
Department of Prasuti Tantra
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi UTTAR PRADESH 221005 India |
| Phone |
9453663997 |
| Fax |
|
| Email |
shikha151984@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shikha Singh |
| Designation |
Assistant Professor |
| Affiliation |
IMS BHU |
| Address |
Department of Prasuti Tantra
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi UTTAR PRADESH 221005 India |
| Phone |
9453663997 |
| Fax |
|
| Email |
shikha151984@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sundarlal Hospital
Faculty of Ayurveda IMS, BHU Varanasi, UP, India
Picode-221005 |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Science Department of Prasuti Tantra |
| Address |
Faculty of Ayurveda
IMS, BHU Varansai, UP, India
Pin code -221005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sarita Saroj |
Sir Sundarlal Hospital |
Faculty of Ayurveda
Department of Prasuti Tantra
IMS BHU Varanasi UTTAR PRADESH |
9598881924
saritaghazipur94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Banaras Hindu University, Institute of Medical Sciences, Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N911||Secondary amenorrhea. Ayurveda Condition: RAJONASAHÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Wheat powder (placebo) | Refereance not available Route oral Dosage form powder Dose 2gm Frequency Qid Duration 3 days Taken with milk | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jyotishmati, vacha, Asan, Swarjika Kshar, Reference: Bhav Prakash, Chikitsa Sthan 70/22-24, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Amenorrhoea of at least 60 days |
|
| ExclusionCriteria |
| Details |
Patients below the age of 18 years and above the age of 40 years.
Pregnant women, lactating mothers, menopause.
Congenital anomalies (mullerian agenesis, cryptomenorrhea)
Surgical Menopause and Oophorectomy.
Patient having organic pathology of uterus & adnexa like cervical carcinoma or any
malignant growth.
Patients having neoplasia and on radiotherapy.
Patients taking any hormone except Thyroxin.
Patients using hormonal contraception (oral/ injectable/transdermal /Intra-uterine)
Patients on Anti-psychotic drugs.
Patients who cannot attend follow-up regularly. Who is participating in another study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Restoration of Menses |
Three follow ups in 5th day 15th day and 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Restoration menstruation & regulation of amount of menstrual flow & pain during menses |
Three follow ups in 5th day 15th day & 1 month |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
15/09/2024 |
| 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 Yet Recruiting |
| 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
|
In the present scenario, menstrual disorder is the commonest gynecological problem in females of the reproductive age group. On account of the disturbance in proper diet, rest, stress, and strain with the change of lifestyle, menstrual disorders have become a very challenging problem for working women or housewife. These may involve structural or functional disturbances and are mostly associated with the complaint of infertility, psychological problems, obesity etc.
Prevalence of secondary amenorrhea has been reported to be 3-4%. Regardless of diagnosis, oligomenorrhoea and amenorrhea are changes in regular menstrual cycles which include long menstrual cycles and absence of menstruation respectively.
The hormonal therapy based on estrogen and progesterone compound is the mainstay of the treatment for these conditions and long-term use of these drugs may produce many side effects. That’s why nowadays there has been an increasing trend in the use of complementary and alternative medicine.
Rajonasha can be correlated with amenorrhea, for which various Shaman and Shodhan drugs are described in the Ayurvedic classics. These all drugs are mainly Agneya. Agneya dravya will increase pitta and Artava due to same properties, with concept of samanya vriddhi karanam.Ayurvedic medicines cure rajonasha by improving Agni and remove of shroto- avarodha. By using these potent Ayurvedic medicines, side effects of the hormonal treatment can be avoided.
Therefore, the present study is undertaken to evaluate the artavajana property of JVAS (Jyotishmati, Vacha, Asan, Swarjikakshar) compound and in the management of Rajonasha.
|