| CTRI Number |
CTRI/2025/04/084467 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study to compare the Efficacy of Nashtapushpantaka Rasa and Rajahpravartini Vati in the treatment of Artavakshaya in females of Polycystic Ovarian Syndrome |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study to Evaluate the Efficacy of Nashtapushpantaka Rasa and Rajahpravartini Vati in the management of Artavakshaya in Polycystic Ovarian 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 |
Mamta Rani |
| Designation |
PhD scholar |
| Affiliation |
Institute of Ayurveda Studies & Research SKAU Kurukshetra |
| Address |
PhD Scholar Department of Prasuti Tantra and Stri Roga Institute of Ayurveda Studies & Research
Faculty of Ayurveda
Shri Krishna AYUSH university Kurukshetra Haryana
Assistant Professor
Department of PTSR
MSM Institute of Ayurveda
BPS Mahila Vishwavidyalaya
Khanpur Kalan Sonepat Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9350952506 |
| Fax |
|
| Email |
docmamta18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitesh Kumar Panda |
| Designation |
Professor |
| Affiliation |
Institute of Ayurveda Studies & Research SKAU Kurukshetra |
| Address |
Guide
Chairperson
PG Department of Prasuti Tantra and Stri Roga
Institute of Ayurveda Studies & Research
Faculty of Ayurveda
Shri Krishna AYUSH university Kurukshetra Haryana
Kurukshetra
HARYANA
138118
India |
| Phone |
9896033056 |
| Fax |
|
| Email |
drjk67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gati Krushna Panda |
| Designation |
Associate Professor |
| Affiliation |
MSM Institute of Ayurveda BPS Mahila Vishwavidyalaya Khanpur Kalan Sonepat Haryana |
| Address |
Co- Guide
Head of department
Department of PTSR
MSM Institute of Ayurveda
BPS Mahila Vishwavidyalaya
Khanpur Kalan Sonepat Haryana
Sonipat
HARYANA
131305
India |
| Phone |
9996454885 |
| Fax |
|
| Email |
dr_gatikrushna@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| MSM Institute of Ayurveda BPSMV Khanpur Kalan Sonepat Haryana |
|
|
Primary Sponsor
|
| Name |
Mamta Rani |
| Address |
Assistant Professor
MSM Institute of Ayurveda BPSMV Khanpur Kalan Sonepat Haryana
|
| 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 |
| DrMamta Rani |
MSM Institute of Ayurveda Hospital BPSMV Khanpur Kalan Sonepat |
OPD No 29 Department of Prasuti Tantra and Stri Roga MSM Institute of Ayurveda Hospital BPSMV Khanpur Kalan Sonepat haryana
Sonipat
HARYANA |
9350952506
docmamta18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee BPSMV Khanpur Kalan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N914||Secondary oligomenorrhea. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nashtapushpantaka Rasa, Reference: Bhaishjyaratnavali chapter67 shloka51 to 56, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 99 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -99 days (28 days intervention -Gap of 5days- 28days- gap 5 days- 28 days-gap 5days) | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rajahpravartini Vati, Reference: Bhaishjyaratnavali chapter 67 shloka 58 to 60, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 99 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -99 days (28 days intervention -Gap of 5days- 28days- gap 5 days- 28 days-gap 5days) |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Females having PCOS assessed on Rotterdam criteria
-2outof3
-oligo-and or anovulation
-clinical and or biochemical signs of hyperandrogenism
-polycystic ovaries in USG
Patient is ready to provide signed informed consent
|
|
| ExclusionCriteria |
| Details |
PCOS with heavy menstrual bleeding or menorrhagia or metrorrhagia.
Females less than 18 yrs. and more than 40 yrs. of age.
Females having primary amenorrhea.
Females having physiological secondary amenorrhea due to lactation.
Females with any organic pelvic lesions like fibroid uterus, adenomyosis, PID etc.
Females with hypo and hyper thyroidism.
Patients with chronic systemic illness.
Patients using oral contraceptive pills.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in Menstrual cycle length intermenstrual period amount and quality of bleeding.
In USG changes in ovarian volume and polycystic appearance of ovary.
Changes in hormone levels serum FSH LH LH FSH ratio Prolactin testosterone etc
|
baseline and after 99 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in hirsutism based on Ferriman- Gallway score.
Changes in Quality of Life using PCOS-Qol Scale.
|
baseline and after 99 days
|
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="2"
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
|
The Study is a Randomized, Open label, parallel group comparative clinical study to evaluate and compare the efficacy of Nashtapushpantaka Rasa 250 mg bd and Rajahpravartini Vati 250 mg bd for 99 days in 134 patients with Artavakshaya in Polycystic Ovarian Syndrome will be conducted at one centre in India. Primary Outcome measure will be Changes in Menstrual cycle length, intermenstrual period, amount and quality of bleeding. In USG changes in ovarian volume and polycystic appearance of ovary and Changes in hormone levels serum FSH, LH, Ratio LH FSH, Prolactin, testosterone etc. at baseline and after 99 days. Secondary outcome measure will be Changes in hirsutism based on Ferriman Gallway score and Changes in Quality of Life using PCOS Qol Scale at baseline and after 99 days. |