| CTRI Number |
CTRI/2024/09/073928 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of rajonivritti janya lakshana i.e. perimenopausal symptoms with the use of vayasthaadi yog and compare with jatamansi phanta |
|
Scientific Title of Study
|
A comparative clinical study of Vayasthaadi yog and Jatamansi Phant in the management of Rajonivritti Janya Lakshana with special reference to Perimenopausal Syndrome |
| 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 Shama Parveen |
| Designation |
MS Scholar |
| Affiliation |
Government Ayurveda College, Varanasi |
| Address |
Department of Prasuti Tantra and Stri Roga Government Ayurveda College and Hospital, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8299123679 |
| Fax |
|
| Email |
shamaparveenn123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarika Srivastava |
| Designation |
Assistant Professor [MD] |
| Affiliation |
Government Ayurveda College, Varanasi |
| Address |
Department of Prasuti Tantra and Stri Roga Government Ayurveda College and Hospital, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8707624954 |
| Fax |
|
| Email |
sarikasri2k@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepika Gupta |
| Designation |
Assistant professor [MD] |
| Affiliation |
Government Ayurveda College, Varanasi |
| Address |
Department of Prasuti Tantra and Stri Roga Government Ayurveda College and Hospital, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9839076961 |
| Fax |
|
| Email |
deepikagupta0717@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College,Chaukaghat Varanasi Uttar Pradesh India pincode-221001 |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College,Chaukaghat Varanasi |
| Address |
Government Ayurvedic College,Chaukaghat Varanasi |
| 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 |
| Dr Shama Parveen |
Goverment PG Ayurvedic College and Hospital Chaukaghat Varanasi |
Department of Prasuti Tantra and Stri Roga, OPD 1 and 36
Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH |
8299123679
shamaparveenn123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Goverment Ayurveda CollegevANd Hospital Varanasi ,UP |
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: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Vayasthaadi yog, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Go-Dugdha), Additional Information: This yoga contain total four medicine, like Guduchi (Vayasthaa),Ashwagandha, Yasthimadhu and Satavari; According to nomenclature of medicine first drug of this yog is Guduchi (Vayasthaa);so here name of yoga Vayasthaadi yog is given. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatamansyadi kashaya, Reference: Bhaishjya Ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Patients willing for trial
Female with age 40-55 years.
Hb greater than 10 g/dl
Patients have no any chronic systemic illness.The patients who are fullfilling diagnostic criteria. |
|
| ExclusionCriteria |
| Details |
Patient with malignant changes on pap smear.Women with medical conditions such as-Diabetes Mellitus, Hypertension, etc. Women on OCPs (Oral Contraceptive Pills) and harmone replacement therapy (HRT).Patient with acute Pelvic Inflammatory Disease.
Patient with acute Urinary Tract Infection..Patient with any genital growth. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in menopausal symptoms - hot falshes, dyspareunia, urinary incontinence, vaginal dryness, mood swings |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in general condition like irrgular menses hot flashes night sweats vaginal dryness changes in mood like irritability depression mood swings |
6 week |
|
|
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)
|
26/09/2024 |
| Date of Study Completion (India) |
31/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Effect of Vayasthaadi Yog in the Management of Rajonivritti Janya
Lakshana (Menopausal Symptoms),
Issue 4 [Jul- Aug] Year 2025 ,
Manuscript Information
ISSN No: 2583-7397
Received: 21-06-2025
Accepted: 02-08-2025
Published: 21-08-2025
IJCRM:4(4); 2025: 576-580
©2025, All Rights Reserved
Plagiarism Checked: Yes
Peer Review Process: Yes |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Interventional study
“A Comparative clinical study of
Vayasthaadi yog and Jatamansi Phant in the management of Rajonivritti Janya
Lakshana with special reference to Perimenopausal Syndrome.” Total Patient - 60
Treatment plan-
Group -A It consisted of 30 patients who were given VAYASTHAADI YOG in a dose of 3 g/day, in two divided doses, orally with 100 ml of lukewarm milk for 3 months, during Rasayana Kala and Nishakaal, before meals.”
Group- B It also consists of 30 patients who were given JATAMANSI PHANT for 3 consecutive months. dose- 40ml /BD in rasayan kala and nishakaal before meal
Follow Up- The treatment is continued for period of 3 months. The patient will come for follow up on each 15th day up to 90 day
result- 60%
patients in group A showed marked improvement, 30% showed moderate improvement,
10% with mild improvement and no patient with no improvement.
In
group B, 40% showed moderate improvement, 10% with mild improvement and 50%
patients with no improvement.
So,
it is clear that group A is more effective than group B. v 60%
patients in group A showed marked improvement, 30% showed moderate improvement,
10% with mild improvement and no patient with no improvement.
In
group B, 40% showed moderate improvement, 10% with mild improvement and 50%
patients with no improvement.
So,
it is clear that group A is more effective than group B. |