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CTRI Number  CTRI/2021/03/031891 [Registered on: 10/03/2021] Trial Registered Prospectively
Last Modified On: 17/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Yoga intervention]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative clinical study of dantyadi gutika along with yoga intervention in the management of scanty and delayed menses. 
Scientific Title of Study   A comparative clinical study of dantyadi gutika along with yoga intervention in the management of artavkshaya w.s.r. oligo-hypomenorhhoea. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Simran 
Designation  MD Ayurveda research scholar 
Affiliation  State Ayurvedic college and hospital, Lucknow 
Address  PG department of Prasuti tantra and Stri roga, State Ayurvedic college and hospital, Tulsidas marg Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  7974926877  
Fax    
Email  simmi00.sk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shashi Sharma 
Designation  Reader and HOD Prasuti tantra and Stri roga 
Affiliation  State Ayurvedic college and hospital, Lucknow 
Address  PG department of Prasuti tantra and Stri roga, State Ayurvedic college and hospital, Tulsidas marg Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  8795545443  
Fax    
Email  bedar.shashi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Simran 
Designation  MD Ayurveda research scholar 
Affiliation  State Ayurvedic college and hospital, Lucknow 
Address  PG department of Prasuti tantra and Stri roga, State Ayurvedic college and hospital, Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  7974926877  
Fax    
Email  simmi00.sk@gmail.com  
 
Source of Monetary or Material Support  
State Ayurvedic College and Hospital, Tulsidas marg, Lucknow, 226003 
 
Primary Sponsor  
Name  State Ayurvedic college and Hospital Lucknow 
Address  State Ayurvedic college and Hospital, Tulsi Das Marg, Lucknow 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Simran  State Ayurvedic college and hospital, Lucknow  OPD no-1, Department of Prasuti tantra and Stri roga, State Ayurvedic college and hospital, Tulsidas Marg, Lucknow
Lucknow
UTTAR PRADESH 		 7974926877

simmi00.sk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, State Ayurvedic college and hospital, Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dantyadi Gutika  Dosage – Two Tab of Dantyadi Gutika (weighing 500mg each) twice a day for 3 consecutive cycles with gap of 5 days from the start of menstruation. 
Comparator Agent  Dantyadi gutika along with Yoga Intervention.  Dosage- two tablet of Dantyadi gutika(weighing 500mg each) orally twice a day along with Yoga Intervention for 3 consecutive cycles with gap of 5 days from the start of menstruation. The duration (30 min) of Yoga session will be as follow- Loosening (Shithalikaran vyayam)-5 min Asana(Bhadrasana,Gomukhasana,Dhanurasana,Bhujangasana,Paschimottanasana)-15 min Pranayama-5 min Shavasana-5 min 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Patients fulfilling cardinal symptoms of Artavakshaya mention in ayurvedic classic.
2.Patients between the age group of 18-40 years.
3.Patients willing to participate in the study with proper written consent. 
 
ExclusionCriteria 
Details  1.Patient having systemic diseases which interfere with the present study(HTN,TB, DM, Thyroid disorder and Hyperprolactenamia)
2.Pregnant & Lactating women.
3.Patient on OCPs, IUCD.
4.Congenital anomalies of uterus or ovaries.
5.Patient with any pelvic pathology or malignancy.
6.Hb% less than 8 gm%.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To assess the efficacy of Dantyadi gutika along with Yoga Intervention in the Management of Artavakshaya.
2. To assess the efficacy of trial therapy on subjective parameters like Interval between two cycles, Duration of Bleeding, Amount of blood loss, Grade of pain – assess with the help of VAS scale and Objective parameters like Hb%, ESR, LFT, USG. 		 Final assessment will be done after completion of trial of 4 consecutive menstrual cycles. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the efficacy of trial therapy on subjective parameters like Interval between two cycles, Duration of Bleeding, Amount of blood loss, Grade of pain – assess with the help of VAS scale.  follow up - each menstrual cycle after the clearance of menses during trial. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/03/2021 
Date of Study Completion (India) 22/04/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   The finding of the study will be published in indexed and peer reviewed journal. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The study is entitled as - "A comparative clinical study of dantyadi gutika aling with yoga intervention in the management of artavkshaya w.s.r. oligo-hypomenorhhoea".

Objective of study - To compare the efficacy of Dantyadi Gutika and Dantyadi gutika along with Yoga Intervention in the Management of Artavakshaya w.s.r. to Oligo-Hypomenorhhoea.

Type of study- Randomized comparative open clinical trial.

Administration of trial therapy - Minimum 40 patients having cardinal symptoms of artavkshaya  will be registered into two groups.

Group A -  two tablet of Dantyadi gutika (500 mg each) twice a day with plain water.

Group B –  two tablet of Dantyadi gutika (500 mg each) twice a day with plain water & Yoga Intervention.

      The duration (30 min) of Yoga session will be as follow-

      Loosening (Shithalikaran vyayam) - 5 min

      Asana(Bhadrasana,Gomukhasana,Dhanurasana,Bhujangasana,Paschimottanasana)-15 min                                                               

      Pranayama - 5 min

      Shavasana - 5 min.

Duration of trial- 4 consecutive cycles.

Therapy period- 3 consecutive cycles with gap of 5 day from the start of menstruation.

Follow up during treatment- On the clearance of each menstrual cycle.

Drug free follow up- On the clearance of next menstrual cycle after completion of trial.

CRITERIA FOR SELECTION OF PATIENT

Diagnostic Criteria

Diagnosis will be based on the presence of the cardinal symptom of Artavakshaya.

A. Yathochitakala Adarshanam of Artava - Menstrual cycle > 35 days

B. Alpartavam – a) Duration of bleeding < 2 days

                           b) Decrease in quantity of bleeding (using pad per day 2)

C. Yoni Vedana - Pain during menstruation.

Inclusion criteria:

1. Patients fulfilling cardinal symptoms of Artavakshaya.

2. Patients between the age group of 18-40 years.

3. Patients willing to participate in the study with proper written consent.

Exclusion criteria:

1. Patient having systemic diseases which interfere with the present study(HTN,TB, DM, Thyroid disorder and Hyperprolactenamia.

2. Pregnant & Lactating women.

3. Patient on OCPs, IUCD.

4. Congenital anomalies of uterus or ovaries.

5. Patient with any pelvic pathology or malignancy.

6. Hb% less than 8 gm%.

OUTCOME ASSESMENT : Assessment will be done on the basis of improvement in the sign and symptoms before and after trial through scoring pattern. Subjective Criteria are Interval between two cycles, Duration of Bleeding, Amount of blood loss, Grade of pain – assess with the help of VAS scale and the Objective Criteria are Hb%, ESR, LFT, USG.

 
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