| CTRI Number |
CTRI/2025/12/099060 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
13/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of Acupuncture and RAGA Therapy on sleep in young adults |
|
Scientific Title of Study
|
Comparative study on Effects of TCM Acupuncture Without and With RAGA Therapy on Young Adults with Sleep Difficulties: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRPAHUNI GARG |
| Designation |
MD SCHOLAR (ACUPUNCTURE AND ENERGY MEDICINE) |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy & Yogic Sciences for Women Bhopal MP |
| Address |
Sant Hirdaram Medical College of Naturopathy & Yogic Sciences for Women Bhopal MP. Acupuncture department 2nd floor Room No.10
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
8630375905 |
| Fax |
|
| Email |
gargpahuni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRANKESH SINGH |
| Designation |
PROFESSOR |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy & Yogic Sciences for Women Bhopal MP |
| Address |
Sant Hirdaram Medical College of Naturopathy & Yogic Sciences for Women Bhopal MP. Acupuncture department 2nd floor Room No.10
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
8619485622 |
| Fax |
|
| Email |
drankeshsngh760@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DRANKESH SINGH |
| Designation |
PROFESSOR |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy & Yogic Sciences for Women Bhopal MP |
| Address |
Sant Hirdaram Medical College of Naturopathy & Yogic Sciences for Women Bhopal MP. Acupuncture Department 2nd Floor Room No.10
MADHYA PRADESH
462030
India |
| Phone |
8619485622 |
| Fax |
|
| Email |
drankeshsngh760@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DRPAHUNI GARG |
| Address |
Sant Hirdaram Medical College of Naturopathy & Yogic Sciences for Women Lake Road Sant Hirdaram Nagar Bhopal MP 462030 India |
| 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 |
| DRPAHUNI GARG |
Sant Hirdaram Medical College of Naturopathy & Yogic Sciences for Women, Bhopal (M.P.) |
Sant Hirdaram Medical College of Naturopathy & Yogic Sciences for Women Bhopal MP INDIA 462030 Acupuncture department 2nd Floor Room No.10
Bhopal
MADHYA PRADESH |
8630375905
gargpahuni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
OTHER NEUROLOGICAL CONDITIONS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Acupuncture |
Participants will be briefed about the procedure and will receive daily 30–40 minute acupuncture sessions for 10 days, using stainless steel filiform needles (1 tsun and ½ tsun). Points will be selected based on pulse and tongue diagnosis, along with some specific points HT7,SP6,PC6,EX-HN3. |
| Intervention |
Acupuncture and RAGA Therapy |
Selected Participants will be informed about the procedure beforehand and will receive acupuncture based on pulse and tongue diagnosis using stainless steel filiform needles (1 tsun and ½ tsun). Each 30–40 minute session will be accompanied by 25–30 minutes of flute-based RAGA NEELAMBARI. The intervention will be conducted daily for 10 days.Acupuncture points will be chosen based on pulse examination, along with selected specific points, some of which are HT7,SP6,PC6,EX-HN3. Total Duration of intervention is 10 days.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
The study includes consenting males and females aged 18–30 years with sleep disturbances for at least three months, including difficulty falling or staying asleep, early awakening, poor sleep quality, daytime sleepiness, delayed sleep onset, or frequent nightmares. |
|
| ExclusionCriteria |
| Details |
The study excludes individuals below 18 or above 30 years, those without informed consent, and participants with neurological or major psychiatric disorders. Subjects with serious medical illnesses, those on sleep-altering medications, current substance abusers, night or rotating shift workers, and pregnant females are also excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study aims to assess the improvement in sleep quality following combined TCM acupuncture and RAGA therapy and to compare the effectiveness of each therapy in enhancing sleep outcomes. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study aims to evaluate baseline sleep quality in young adults with sleep difficulties, compare pre- and post-intervention sleep parameters within each group, and assess changes in quality of life after the intervention. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
30/12/2025 |
| 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="1"
Months="6"
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
|
This randomized controlled trial aims to evaluate the effects of Traditional Chinese Medicine (TCM) acupuncture with and without RAGA therapy on sleep quality in young adults with self-reported sleep difficulties. Participants aged 18–30 years experiencing disturbed sleep for at least three months will be randomly assigned to two groups: one receiving TCM acupuncture alone and the other receiving combined TCM acupuncture and RAGA therapy. The study will assess changes in sleep parameters, sleep quality, and quality of life before and after intervention using standardized assessment tools. The findings are expected to determine whether the combination of acupuncture and RAGA therapy provides superior improvement in sleep outcomes compared to acupuncture alone. |