| CTRI Number |
CTRI/2023/08/055990 [Registered on: 01/08/2023] Trial Registered Prospectively |
| Last Modified On: |
31/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Role of Dashang Guggulu and Shatpuspha Churna in PCOD in Corporate Sector Women |
|
Scientific Title of Study
|
A Nidanatmaka Survey Study and Randomized Comparative Clinical Trial of Dashang Guggulu and Shatpuspha Churna in PCOD in Corporate Sector Women |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashmi Temani |
| Designation |
Ph.D Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of RogNidana Evum Vikrati Vigyana,National Institute of Ayurveda,Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7790921434 |
| Fax |
|
| Email |
rashmitemani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Surendra Kumar Sharma |
| Designation |
Professor and head of the department |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of RogNidana Evum Vikrati Vigyana,National Institute of Ayurveda,Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414361874 |
| Fax |
|
| Email |
ssurendr452@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rashmi Temani |
| Designation |
Ph.D Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of RogNidana Evum Vikrati Vigyana,National Institute of Ayurveda,Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7790921434 |
| Fax |
|
| Email |
rashmitemani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Rognidana Evum Vikrati Vigyana,National Institute of Ayurveda,Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda(Deemed to be Novo),Jaipur |
| Address |
Jorawar Singh Gate,Amer Road,Jaipur,302002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rashmi Temani |
Genpact Company |
Plot No.1,JLN Marg,Near Venkateshwara Temple,Siddharth Nagar,Sector 9,Malviya Nagar,Jaipur, Rajasthan
Jaipur
RAJASTHAN |
01414092008
rashmitemani@gmail.com |
| Rashmi Temani |
National Institute of Ayurveda |
Jorawar Singh Gate,Near Amer Road,Jaipur,302002
Jaipur
RAJASTHAN |
01412781515
rashmitemani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Instititional Ethics Committee,National Institute of Ayurveda |
Approved |
| Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N74||Female pelvic inflammatory disorders in diseases classified elsewhere, (2) ICD-10 Condition:N948||Other specified conditions associated with female genital organs and menstrual cycle. Ayurveda Condition: Metabolic Disorders, (3) ICD-10 Condition:N948||Other specified conditions associated with female genital organs and menstrual cycle. Ayurveda Condition: MEDAHSTHITAKAPAKOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatpuspha Churna, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: , Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dashang Guggulu, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: -(2) Medicine Name: Dashang Guggulu, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Female patients of age group between 21 to 40 years (Both married and unmarried)
Patient having two out of three criteria- ASRM/ESHRE (Rotterdam) Criteria,2018
Oligo and /or anovulation
Hyperandrogenism (clinical and /or biochemical).
Polycystic ovaries (Confirmed on USG)
BMI ≥23
|
|
| ExclusionCriteria |
| Details |
ï¶ Patient having any other disease causing oligomenorrhoea and anovulation excluding PCOD on above criteria.
ï¶ Any organic lesions of reproductive tract like T.B., carcinoma and congenital deformities or any other pelvic pathology.
ï¶ Patient suffering from hyperprolactinemia, adrenal hyperplasia, severe insulin resistance, androgen secreting neoplasm, thyroid abnormalities, Cushing’s syndrome, cardiac diseases will exclude.
ï¶ Current or previous (within last 3 months) use of OC pills, Glucocorticoids, anti-androgens, ovulation induction agents, anti-diabetic, anti-obesity drugs, or other hormonal drugs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in Physical Measurement & biochemical investigations for Medodusthi
Changes in serum LH & FSH value
Change in USG Report & other laboratory investigations for Aartavdusthi.
|
90 Days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in the Subjective Parameters of Medodusthi
and Aartavdusthi |
90 Days |
|
|
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 2 |
|
Date of First Enrollment (India)
|
10/08/2023 |
| 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="1"
Days="10" |
|
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 ayurveda conditions can correlate with PCOD like Yonivyapada (genital disorders), Ashtoartavadushti3 (menstrual disorders) and Nashtartava4 (secondary amenorrhea). The features of PCOD may also be correlated with Pushpaghni Jataharini5 having the clinical features like Sthoulya (obesity), Lomashaganda (hirsutism) or hairy and corpulent cheeks and Vrithapushpa (unfruitful ovulation/anovulation) with menstrual
irregularities. Considering
the pathology i.e formation and accumulation of cyst in periphery of ovary, PCOD
bear similar symptom as Granthi also Sthoulya Samprapti6 & Prameha Samprapti7 also
possesses some clinical features similar to PCOD. According to Bhavprakasha8, in female rajah srava
occurs monthly, which causes purity
of sharirika dosha. This
monthly purification of doshas prevent prameha in females. As whole metabolic process is disturbed in PCOD
which is considered as dhatwagni vikara . |